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Research Guide
Mr. Nimish Deshpande
Asst. Professor
Department of Business Management
Padmashree Dr. D.Y. Patil University
CBD Belapur, Navi Mumbai
March 2014
DECLARATION
I, Swapnil Rathore hereby declare that the dissertation Study of the Anti-Diabetic
Market and Doctors Perception Regarding the Drugs Used In Diabetes Mellitus
submitted for the MBA Degree at Padmashree Dr. D.Y. Patil Universitys
Department of Business Management is my original work and the dissertation has
not forme d the basis for the award of any degree, associate ship, fellows hip or any
other similar titles.
Place: Mumbai
Date:
CERTIFICATE
This is to certify that the dissertation entitled To study the anti- diabetic
market to study the doctors perception regarding the drugs used in diabetes. is
the bonafide research work carried out by Mr.Swapnil Rathore student of
MBA, at Padmashree Dr. D.Y. Patil Unive rsity Department of Business
Management during the year 20012-2014, in partial fulfillment of the
require ments for the award of the Degree of Master in Business Management
and that the dissertation has not formed the basis for the award previously of
any degree, diploma, associate ship, fellowship or any other similar title.
Dr. R. Gopal,
Director & HOD
(Assistant Professor)
ACKNOWLEDGEMENT
In the first place, I thank Prof. Mr. Nimish Deshpande, Assistant Prof, Department of
Business Management, Padmashree Dr. D.Y.Patil University, Navi Mumbai for
having given me his valuable guidance for the project. Without his help it would have
been impossible for me to complete the project.
It is a matter of pleasure for me to work on a practical project like Study of the antidiabetic market and doctors perception regarding the drugs used in diabetes .This project
has added value to my theoretical knowledge. I would like to admit my sincere thanks to
the various people from Pharma industry & doctors who have provided me a lot of
information and data many of which I have used in this project and without which this
project could not have been completed.
I would be failing in my duty, if I do not acknowledge with a deep sense of gratitude the
sacrifices made by my parents, and those who helped me in completing project work
successfully.
Place: Mumbai
Date:
Signature of Student
PREFACE
Decision making is a fundamental part of the research process. Decisions regarding that
what you want to do, how you want to do, what tools and techniques must be used for the
successful completion of the project. The topics having aroused my curiosity,
discussions were held with several people in the Pharma sector to understand the
veracity of the above thought process and also understand the real issues of the industry.
Basically when we are playing with computer in every part of life, I used it in my project
not for the ease of my but for the ease of result explanation to those who will read this
project. The project presents the current market scenario of anti-diabetic market .
I had come across several difficulties to make the objectives a reality. I am presenting this
hand carved efforts in black and white. All these aspects then resulted in the
development of the project report titled Study of The Anti-Diabetic Market And
Doctors Perception Regarding The Drugs Used In Diabetes Mellitus.
It is strongly hoped that this project covers not only the various requirements of the
Project Study but also of the Industry.
TABLE OF CONTENTS
TABLE OF CONTENTS
EXECUTIVE SUMMARY ................................................................................................. 7
RESEARCH METHODOLOGY......................................................................................... 9
DATA COLLECTION................................................................................................... 10
OBJECTIVE OF THE STUDY ......................................................................................... 13
INDUSTRY DEFINITIONS ............................................................................................. 15
DIABETES IN INDIA....................................................................................................... 16
The Risk Factors for Diabetes in Indians Are:............................................................... 16
Introduction of disease: .................................................................................................. 19
RESEARCH....................................................................................................................... 20
Objectives of research : .................................................................................................. 20
INTRODUCTION ............................................................................................................. 21
Types of Diabetes........................................................................................................... 24
DATA ANALYSIS & DATA INTERPRETATION ........................................................ 83
Data Analysis and Interpretation for Chemist Questionnaire ........................................ 93
CONCLUSION................................................................................................................ 101
LIMITATION OF THE STUDY ..................................................................................... 102
SUGGESTION AND RECOMMENDATION................................................................ 103
APPENDIX ...................................................................................................................... 104
ANNEXURE-I ............................................................................................................. 104
ANNEXURE-II ............................................................................................................ 108
ANNEXURE-III........................................................................................................... 110
ANNEXURE-IV .......................................................................................................... 112
ANNEXURE-V............................................................................................................ 114
EXECUTIVE SUMMARY
Diabetes is the syndrome of having excess blood sugar due to low levels of
insulin or insulin resistance. Approximately 21 million individuals in the U.S. have
diabetes, and this number is growing at 10% a year, or over 1.5 million new cases
annually. According to a new report published by Transparency Market Research .The
Global Market for Diabetes Management accounted for USD 40 billion in 2010 and is
expected to attain a market size of around USD 114 billion following a growth rate of
13.5% CAGR. The major products in this market consists of glucose meters, test strips,
lancets, continuous blood glucose meters, syringes, insulin pumps, insulin and other
insulin delivery devices and anti-diabetic drugs. However, insulin, test strips and antidiabetic drugs are the most revenue generating products.
Market Research is one of the most important function that a company or any
organization performs to identify its environment and adapt according to it .The title of
project is Study of the Anti-Diabetic Market and Doctors Perception Regarding the
Drugs Used In Diabetes Mellitus. The objective of project is to find out the market of anti
spasmodic drugs, and also to find out what are trends of drugs mostly used by physicians.
The project is based on research of anti diabetes drug in market which are available in
market.
The project, the method adapted for primary data collection was survey (through
Questionnaire) method. This method was selected and used as it is extremely flexible and
more or less economic. Also some secondary data was collected through doctors enquiry
and searching on the internet .During this project I had to face vario us problems regarding
the survey responses.
For the collection of primary data on Huminsulin (r) , I take a sample size 50 including
General physician & Diabetalogist .
The communication with doctor during survey concluded that the number of patients are
increasing day by day. one of senior doctor told that initially diabetes was very less as
compared to present. it can be said that the diabetes is increasing in double ratio specially
in old age people.
The survey from all doctor concluded that both type of diabetes patient i.e. non- insulin
dependent diabetes mellitus (NDDM) and insulin dependent diabetes mellitus (IDM)
approach to doctor.
Patients has to regularly monitor glucose level with glucometer like instruments. Diabetes
patient also need to take lot of care in diet and the medicine should be taken from time to
time. The IDDM patient need to take regularly subcutaneous injection of insulin. the
missing of drug dose and carelessness in diet can lead to threatening condition patient
may need to hospitalized.
The doctor also said that the fast food is also responsoible for increasing diabetes
patients. So they advice to take proper calorie food which is needed by patients.
7
.While in case of NIDD doctors like to preffered drug as well as insulin injection. but the
diabetes can be controlled mostly by taking drug tolbutamide, chlorpropmide, metformin,
sitagliptin etc. regularly.
The most doctors said that the cost of treatment is affordable to patient is not sufficient
while few come to conclusion it may or may not be.
The near about 25% doctor said that there is not that much side effect which can be
neglected but there is only need to take proper dose should be given to patients according
to situation. some said there are side effect depend on patient physiology so few doctor
said that side effect can be or not.
The survey concluded that all doctors know about both brands metformin and huminsulin.
They said brands are most commonly prescribed. There is no hesitation in writing these
brands. Both brands have given excellent result. The patient to whom this brands are
prescribed they have given positive response.
No. of patients suffering from diabetes is constantly increasing; India is set to become the
global hub of diabetes in the coming decade. It is more prevalent amongst males.
Prediabetes is a stage between normal and diabetes stage. It is an alarming sign for
upcoming diabetes or a chance to change your future
Type 1 is treated with insulin replacement therapy usually by injection or insulin
pump, along with attention to dietary management, typically including carbohydrate
tracking, and careful monitoring of blood glucose levels using Glucose meters.
Now a days Diabetes is a very common disorder in India as well as through out the wor ld.
Every fifth person is suffered by the diabetes disorder. India is an expanding stage in
Anti-diabetic market. In coming few years India is become the top position for diabetic
patient/Market.
The aged (old) people suffer more towards the diabetes diso rder. There are lots of factors
responsible for diabetes.
RESEARCH METHODOLOGY
Research refers to a search for knowledge. It is a systematic method of
collecting and recording the facts in the form of numerical data relevant to the formulated
problem and arriving at certain conclusions over the problem based on collected data.
Thus formulation of the problem is the first and foremost step in the research process
followed by the collection, tabulation and analysis and drawing the conclusions.
SURVEY METHOD
The most widely used technique of gathering primary data is the survey method. The
sources interviewed personally at the place of work and also with questionnaires. It is a
direct and more flexible form of investigation involving face- to- face communication and
through recorded questionnaires filled in personally.
DATA COLLECTION
Type of Research:
Quantitative Research
Sample size:
Sample unit:
10
INTRODUCTION
Diabetes is a chronic disease that occurs when the pancreas does not
manufacture enough insulin, or alternatively, when the body cannot effectively use the
insulin it produces. Insulin is a hormone that controls the sugar level in the
bloodstream. If the sugar is not converted into energy for the body to use, it builds up.
In the long term, too much sugar, or glucose, in the body can lead to damage to the
heart, blood vessels, eyes, kidneys and nerves. The level of glucose in the blood can
also fluctuate throughout the day and needs to be closely monitored and controlled. As
a direct consequence of the continuing rise in diabetes, the market for diabetes
monitoring and controlling products continues to grow. Diabetes is often closely
associated with the weight condition and general health of an individual. A lack of
regular exercise and tendency toward obesity of the global population will likely drive
up incidence rates of diabetes. This trend is expected to continue as the World Health
Organization (WHO) projects an escalating prevalence worldwide as more cases are
identified. Progress in finding new treatments in care, new products (both therapeutic
and diagnostic), new developments in long-term treatments, and maturing public health
priorities will continue to create new shifts in the diabetes care industry. No. of patients
suffering from diabetes is constantly increasing; India is set to become the global hub
of diabetes in the coming decade. It is more prevalent amongst males. Calorie rich
diet, obesity and genetic factors are considered to be the main factors responsible
for diabetes. Precautions that doctors recommend would be important to note.
Due to the growing incidence and chronic nature of the disease, a drift
towards Ayurvedic and other alternate forms of medicine may be occurring. The
current shift, if any, may foretell trends. Diabetes gives rise to a host of other
complications. Knowing their incidence can give valuable inputs for coprescription, parallel prescription, product development/ improvement/ combinations
etc.
Dibetes has become very much a lifestyle disease in the metros with the
number of patients, especially in the younger age groups, sharply increasing. Thus,
knowing doctors opinions (GPs and Specialists) on the same can give valuable
insights as to the current trends. Diabetes gives rise to a host of other complications.
Knowing their incidence can give valuable inputs for co-prescription, parallel
prescription, product development/ improvement/ combinations etc.
Diabetes has become very much a lifestyle disease in the metros with the
number of patients, especially in the younger age groups, sharply increasing. Thus,
knowing doctors opinions (GPs and Specialists) on the same can give valuable
insights as to the current trends.
The main idea of the project is know how Anti-diabetic market going through
there in the basis of improved research and development. This project give the analysis
11
of Indian Anti-diabetic market and also indicates that it is in booming stage Finally it
also the aim the Indian pharma industry is one of the competitive industry in the Indian
market as well as world market like China, US etc.
12
Diabetes
treatment
is expensive.
According
to the
American Diabetes Association, people who have this disease spend an average of
$13,243 a year on health care expenses. Hence the need for insurance plan that
covers as many diabetes-related expenses as possible. This has caused a further
challenge for the healthcare environment. An individual with diabetes can be
confronted with trouble in obtaining and keeping health insurance and life
insurance. Approximately 21 million American children and adults are victims of
diabetes, but a significant share of these are uninsured and cannot gain access to the
supplies, medications, and education necessary to effectively handle the disease.
14
INDUSTRY DEFINITIONS
Hypoglycemia - a condition that occurs when blood glucose is lower than
normal,
usually less than 70 mg/dL. Signs include hunger, nervousness, shakiness, perspiration,
dizziness or light- headedness, sleepiness, and confusion.
Hype rglycemia a condition of excessive blood glucose. Fasting hyperglycemia is
blood glucose above a desirable level after a person has fasted for at least 8 hours.
Diabetes insipidus - A condition characterized by frequent and heavy urination,
excessive thirst and an overall feeling of weakness. This condition may be caused
by a defect in the pituitary gland or in the kidney. In diabetes insipidus, blood
glucose levels are normal.
Diabetes mellitus - A condition characterized by hyperglycemia resulting from the
body's inability to use blood glucose for energy.
Type 1 Diabetes - In Type 1 diabetes, the pancreas no longer makes insulin and
therefore blood glucose cannot enter the cells to be used for energy.
Type 2 Diabetes - In Type 2 diabetes, either the pancreas does not make enough
insulin or the body is unable to use insulin correctly
Fasting blood glucose - A method for learning how much glucose (sugar) there is in
a blood sample taken after an overnight fast. The fasting blood glucose test is
commonly used in the detection of diabetes mellitus. The normal, range for blood
glucose is from 70 to 110 mg/dl, depending on the type of blood being tested. If the
level is over 140 mg/dl, it usually means the. Person has diabetes (except for newborns
and some pregnant women).
Insulin - a hormone that regulates the amount of glucose (sugar) in the blood and is
required for the body to function normally. Cells in the pancreas, called the islets of
Langerhans, produce insulin.
Blood glucose monitoring - checking blood glucose level on a regular basis in order to
manage diabetes is called blood sugar monitoring. A blood glucose meter (or blood
glucose test strips that change color when touched by a blood sample) is needed for
frequent blood glucose monitoring.
Thiazolidinedione - a class of oral medications for Type 2 diabetes that helps insulin
take glucose from the blood into the cells for energy by making cells more sensitive to
insulin.
(Generic names: pioglitazone and rosiglitazone)
15
DIABETES IN INDIA
Curre nt Status:Diabetes has emerged as a major healthcare problem in India. According
to Diabetes Atlas published by the International Diabetes Federation (IDF), there were
an estimated 40 million persons with diabetes in India in 2007 and this number is
predicted to rise to almost 70 million people by 2025. The countries with the largest
number of diabetic people will be India, China and USA by 2030. It is estimated that
every fifth person with diabetes will be an Indian. Due to these sheer numbers, the
economic burden due to diabetes in India is amongst the highest in the world. The real
burden of the disease is however due to its associated complications which lead to
increased morbidity and mortality. WHO estimates that mortality from diabetes, heart
disease and stroke costs about $210 billion in India in the year 2005. Much of the heart
disease and stroke in these estimates was linked to diabetes. WHO estimates that
diabetes, heart disease and stroke together will cost about $ 333.6 billion over the next
10 years in India alone?
Rapid urbanization and industrialization have produced advancement on the
social and economic front in developing countries such as India which have resulted in
dramatic lifestyle changes leading to lifestyle related diseases. The transition from a
traditional to modern lifestyle, consumption of diets rich in fat and calories combined
with a high level of mental stress has compounded the problem further. There are
several studies from various parts of India which reveal a rising trend in the prevalence
of type II diabetes in the urban areas. A National Urban Survey in 2000 observed that
the prevalence of diabetes in urban India in adults was 12.1 per cent per cent. Recent
data has illustrated the impact of socio-economic transition occurring in rural India.
The transition has occurred in the last 15 years and the prevalence has risen from 2.4 per
cent to 6.4 per cent.
Central ObesityThe association of obesity with Type II Diabetes is well known. Even
with an acceptable body weight range, weight gain could increase the risk of diabetes.
An excess of body fat specially concentrated within the abdomen has an increased risk of
diabetes. The cut-off limit for waist circumference for Indians has been recommended to
be 90 cm for males and 80 cm for females. Abdominal obesity is defined by waist
circumference above these limits.
Physical Inactivity and Sedentary LivingThere is enough evidence to demonstrate
that physical inactivity as a independent factor for the development of type II diabetes.
The availability of motorised transport and a shift in occupations combined with the
plethora of television programmes has reduced the physical activity in all groups of
populations.
Insulin Resistance Asian Indians have been found to be more insulin resistant as
compared to the white population. They have a higher level of insulin to achieve
the same the blood glucose control. A cluster of factors consisting of abnormal fats
(Dyslipidemia), high blood pressure, obesity, and abnormal glucose levels known
as metabolic syndrome is highly prevalent in Asian Indians.
UrbanisationThe developing countries like India are undergoing rapid urbanisation .
Urbanisation is associated with increasing obesity, decreasing physical activity due to
changes in lifestyle, diet and a change from manual work to less physical occupations.
StressThe impact of stress both physical and mental along with lifestyle changes has
a strong effect of increasing incidence of type II Diabetes amongst persons is a strong
genetic background. In a recent study in Chennai, nearly 25 per cent of the population
studied was unaware of a condition called diabetes. Only 40 per cent of the participants
felt that prevalence of diabetes was increasing and only 22 per cent of the population
felt that diabetes could be prevented. Though the awareness levels increased with
education, only 42.6 per cent of postgraduates and professionals including doctors knew
that diabetes was preventable. The knowledge of risk factors was even lower, only 11.9
per cent of the study subjects reported obesity and physical inactivity as risk factors.
Even amongst the known diabetics, only 40.6 per cent were aware that diabetes could
lead to some organ damage and complications. Many people (46 per cent) with diabetes
felt that it was a temporary phenomenon.
In a study in 1998, Diabcare Asia Study, it was observed that of all the patients with
diabetes taking treatment from specialized centers, more than 50 per cent of patients
had poor control of diabetes as per the criteria of American Diabetes Association. The
Study showed that four per cent of patients were on diet therapy alone, 53.9 per cent
were receiving oral antidiabetic agents, 22 per cent of the patients were taking insulin
and another 19 per cent were on both insulin and oral drugs. This Study confirmed that
diabetes care in India leaves much to be desired.
In two other studies carried out in Bangalore and South India, it was observed that
majority of patients (70 per cent) were diagnosed by their general practitioners (GP)
17
and 70 per cent of them had approached the GP for some other problem. 90 per cent
of them underwent only Fasting and Post Meal Blood Sugar and Urine Sugar Tests.
Specialized tests such as Glycosylated Hemoglobin (HbA1C), lipid profile, kidney
Function test were undertaken by only four-six percent of patients. Even simple
measurement of blood pressure, weight and examination of feet were not done for
majority of patients.
In India, the lack of proper healthcare infrastructure, rampant ignorance
and absence of clear cut guidelines mean that approach to the management of
diabetes is ad hoc. The lack of awareness among patients and General Practitioners
(GPs) is a key factor in the poor care. There are practically no nurse educators or
diabetic counselors, no podiatrists (foot experts) and very few dieticians who mean
that the treating doctor has no support and has to take the entire burden of caring for
these patients. The patients' inability/unwillingness to pay for this additional support
also hinders the treatment.
Even after the diagnosis, monitoring of diabetes is very poor. Most of the
patients initially visit a doctor and then discontinue their therapy once their symptoms
and controlled. A majority of the patients abandon modern allopathic treatment in
favors of indigenous treatments. Further, more patients with poor control avoid insulin
for fear of injection and belief of addiction of insulin. Hence they keep changing
doctors and hop from one system of treatment to another leading to further
complications and early death. Lack of resources, medical reimbursement and poor
state funding for diabetes is a barrier to quality care often because the patient is unable
to afford the high cost of treatment.
There is ample evidence to suggest that preventive measures to reduce the burden of
diabetes are needed. The US Diabetes Prevention Programme and the Finnish Diabetes
Prevention Programme and the Chinese Study have conclusively proved that lifestyle
modification including weight loss, increased physical activity and dietary changes can
prevent or delay the onset of diabetes. The need of the hour is direct public education
and mass media campaigns, awareness about diabetes and its complications. There is a
need to spread the message that diabetes is preventable and we need to have a
behavioral change to adopt a healthy lifestyle.
18
Introduction of disease:
History and Statistic
Diabetes is not a newly born disease, it has been with human race from
long back but, we came to knew about it in 1552 B.C. Since this period, many of
Greek as well French physicians had worked on it and made us aware of the nature of
disease, organs responsible for it etc. In 1870s, a French physician had discovered a
link between Diabetes and diet intake, and an idea to formulate individual diet plan
came into picture.
Diabetic diet was formulated with inclusion of milk, oats and other fiber
containing foods in 1900-1915. Function of insulin, its nature, along with its use started
from 1920 -1923, discovered by Dr. Banting, Prof. Macleod and Dr .Collip, who were
awarded a Noble prize. In the decade of 1940, it has been discovered that different
organs like kidney and skin are also affected if diabetes is creeping from a long term. A
major turn in this research was in the year 1955, when the oral hypogycemic drugs had
been manufactured. Diabetes was recognized with complete details and its types (Type
1and Type 2 diabetes - that is insulin dependent and non insulin dependent) in the year,
1959. As we know this is one of the old diseases, existing in many individuals and still
on rising charts. Hence, scientists are continuously working to relieve us from it, by
discovering the relevant drugs and making new researches.
19
RESEARCH
Research in common parlance refers to a search for knowledge. Once can
also define research as a scientific and systematic search for pertinent information on a
specific topic. In fact, research is an art of scientific investigation. The Advanced
Learners Dictionary of Current English lays down the meaning of research as a careful
investigation or inquiry specially through search for new facts in any branch of
knowledge.1 Redman and Mory define research as a systematized effort to gain new
knowledge.2 Some people consider research as a movement, a movement from the
known to the unknown. It is actually a voyage of discovery. We all possess the vital
instinct of inquisitiveness for, when the unknown confronts us, we wonder and our
inquisitiveness makes us probe and attain full and fuller understanding of the unknown.
This inquisitiveness is the mother of all knowledge and the method, which man employs
for obtaining the knowledge of whatever the unknown, can be termed as research.
Research is an academic activity and as such the term should be used in a technical sense.
According to Clifford Woody research comprises defining and redefining problems,
formulating hypothesis or suggested solutions; collecting, organising and evaluating data;
making deductions and reaching conclusions; and at last carefully testing the conclusions
to determine whether they fit the formulating hypothesis. D. Slesinger and M. Stephenson
in the Encyclopaedia of Social Sciences define research as the manipulation of things,
concepts or symbols for the purpose of generalising to extend, correct or verify
knowledge, whether that knowledge aids in construction of theory or in the practice of an
art.3 Research is, thus, an original contribution to the existing stock of knowledge
making for its advancement. It is the persuit of truth with the help of study, observation,
comparison and experiment. In short, the search for knowledge through objective and
systematic method of finding solution to a problem is research. The systematic approach
concerning generalisation and the formulation of a theory is also research. As such the
term research refers to the systematic method.
Objectives of research :
The purpose of research is to discover answers to questions through the
application of scientific procedures. The main aim of research is to find out the truth
which is hidden and which has not been discovered as yet. Though each research study
has its own specific purpose, we may think of research objectives as falling into a number
of following broad groupings:
1. To gain familiarity with a phenomenon or to achieve new insights into it (studies with
this object in view are termed as exploratory or formulative research studies)
2. To portray accurately the characteristics of a particular individual, situation or a group
(studies with this object in view are known as descriptive research studies)
3. To determine the frequency with which something occurs or with which it is associated
with something else (studies with this object in view are known as diagnostic research
studies);
4. To test a hypothesis of a causal relationship between variables (such studies are known
as hypothesis-testing research studies).
20
INTRODUCTION
Sweet has no place in this life. Everyone and everything has turned bitter.
This is the pathetic condition of a diabetic patient. Once detected of diabetes, the world
becomes a bitter one. Hereditary and environmental reasons like lack of exercise and
obesity can be the real cause of this disease. Still the mystery that hovers above the
disease continues. Immense papers are published; the scientific fraternity is toiling day
and night to decipher the exact cause of the disease. The general condition of the body
that does not produce insulin or use it in a proper manner is called diabetes.
Diabetes is a metabolic disorder where in human body does not produce
or properly uses insulin, a hormone that is required to convert sugar, starches, and other
food into energy. Diabetes mellitus is characterized by constant high levels of blood
glucose (sugar). Human body has to maintain the blood glucose level at a very narrow
range, which is done with insulin and glucagon. The function of glucagons is causing
the liver to release glucose from its cells into the blood, for the production of energy
And what is this insulin? Insulin is the hormone that regulates glucose levels in the
blood The FPG (Fasting Plasma Glucose) test or OGTT (Oral Glucose Tolerance Test)
determines whether you are diabetic or not. The FPG test is the more economical,
fastest and easiest test. If the blood sugar level is between 100 and 125mg/dl on the
FPG test then it denotes pre- diabetes and if it is 126mg/dl or above the person suffers
from diabetes. . Desired blood sugar of human body should be between 70 mg/dl -110
mg/dl at fasting state.
If blood sugar is less than 70 mg/dl, it is termed as hypoglycemia and if more than 110
mg /dl, its hyperglycemia Both lead to hyperglycemia where urine is produced
excessively, vision is blurred, lethargy, weight loss, and increased fluid intake. With
the discovery of insulin from 1921, diabetes has become treatable and manageable.
Type 1 diabetes is treated by administering insulin externally either by syringe or
insulin pump. Type 2 is treated by dietary supplements and insulin recommendations.
A hormone that is required to convert sugar, starches, and other food into
energy. Diabetes mellitus is characterized by constant high levels of blood glucose
(sugar).
Human body has to maintain the blood glucose level at a very narrow
range, which is done with insulin and glucagon. The function of glucagons is causing
the liver to release glucose from its cells into the blood, for the production of energy.
There are three main types of diabetes:
Type 1 diabetes
Type 2 diabetes
Gestational diabetes
Type 1 and Type 2 diabetes impede a persons carefree life. When breakdown of
21
glucose is stopped completely, body uses fat and protein for producing the energy.
Due to this mechanism symptoms like polydipsia, polyuria, polyphegia, and
excessive weightloss can be observed in a diabetic.
Diabetes is the primary reason for adult blindness, end-stage renal
disease (ESRD), gangrene and amputations. Overweight, lack of exercise, family
history and stress increase the likelihood of diabetes. When blood sugar level is
constantly high it leads to kidney failure, cardiovascular problems and neuropathy.
Patients with diabetes are 4 times more likely to have coronary heart disease and
stroke. In addition, Gestational diabetes is more dangerous for pregnant women and
their fetus. Though, Diabetes mellitus is not completely curable but, it is controllable
to a great extent.
So, you need to have thorough diabetes information to manage this it
successfully.
The control of diabetes mostly depends on the patient and it is his/her
responsibility to take care of their diet, exercise and medication. Advances in diabetes
research have led to better ways of controlling diabetes and treating its complications.
Hence they include:-
New improved Insulin and its therapy, (external and implantable insulin
pumps)
have advanced well to manage elevated blood sugars without any allergic reactions.
Oral hypoglycemic drug,
controls diabetes type 2.
New improved blood glucose monitor (new device for self blood glucose monitoring),
and hemoglobin A1c laboratory test to measure blood glucose control during previous 3
months. Effective availability of the treatments for affected body organs due to
diabetes.Better ways to manage mother and its fetus health during the gestational
diabetes phase.
Prediabetes
Prediabetes is a stage between normal and diabetes stage. It is an
alarming sign for upcoming diabetes or a chance to change your future. Universally,
numerous terms are given like, Borderline Diabetes, Chemical Diabetes, Touch of
Diabetes etc. The term Prediabetic was given by the US Department of Health And
Human Services and ADA on 27th march 2002 with an intention to create awareness
and convey seriousness of the condition. Also, they motivated people to opt for
appropriate treatment and lifestyle modification.
According to the ADA statistics 17 million US citizens are diabetic and 16 millions are
prediabetic. ADA defines it as a stage before the development of diabetes, with normal
glucose tolerance, but with an increased risk of developing diabetes in near future.
22
Prediabetes is a condition when your blood sugar level triggers higher than normal, but
not so high that we can justify it as type 2 diabetes. According to the Centers for
Disease Control and Prevention,
41 million U.S. adults aged 40 to 74 have prediabetes. And the same reports from, The
American Academy of Pediatrics show that, one of every 10 males and one of every 25
females have prediabetes aged from 12 to 19 years.
Signs and Symptoms of Prediabetes
Prediabetes can take a long time to transform finally as diabetes. It has
been generally observed that prediabetes will eventually convert to diabetes but, at the
same time, there are greater possibilities to revert back to
normal if, taken care seriously. People suffering from prediabetes may show same
symptoms as in diabetes but, they will be erupting occasionally like:
Excessive thirst
Tingling sensations in feet and fingers
Excess-Hunger
Frequent-Urination
Irritability
Frequent infections
Blurred vision
Skin itching
People - In Risk Zone: Some individuals are at more risk of prediabetes than others due
to presence of these factors Being overweight
Family history of prediabetes
Waist hip ratio - The person with 'fat tire'
Depression and stress
Causes: Prediabetic is a person suffering from little high sugar than normal patients.
The reason behind high sugar is entry of glucose into the blood cells due to disturbance
in the mechanism of insulin. Thus, sugar is circulating in the blood stream but unable to
peetrate into cells and tissue, to produce energy. The exact reason for this is uncertain
but it is considered that overweight and fatty tissues along with sedentary lifestyle are
the correlating factors.
23
Types of Diabetes
1) Type 1 diabetes
Diabetes mellitus type 1 (type I diabetes, T1D, T1DM, IDDM, juvenile
diabetes) is a form of diabetes mellitus. Type 1 diabetes is an autoimmune disease that
results in destruction of insulin- producing beta cells of the pancreas. Thus far, such
destruction has been permanent, but there is informed speculation that reversing the
immune system malfunction may allow recovery of beta cell function. Lack of insulin
causes an increase of fasting blood glucose (around 70-120 mg/dL in nondiabetic
people) that begins to appear in the urine above the renal threshold (about 190-200mg/dl
in most people), thus connecting to the symptom by which the disease was identified in
antiquity, sweet urine. Glycosuria or glucose in the urine causes the patients to urinate
more frequently, and drink more than normal (polydipsia). Classically, these were the
characteristic symptoms which prompted discovery of the disease.
Type 1 is lethal unless treated with exogenous insulin. Injection is the
traditional and still most common method for administering insulin; jet injection,
indwelling catheters and inhaled insulin has also been available at various times, and
there are several experimental methods as well. All replace the missing hormone
formerly produced by the now non-functional beta cells in the pancreas.
In recent years, pancreas transplants have also been used to treat type 1
diabetes. Islet cell transplant is also being investigated and has been achieved in mice
and rats, and in experimental trials in humans as well. Use of stem cells to produce a
new population of functioning beta cells seems to be a future possibility, but has yet to
be demonstrated even in laboratories as of 2008.
Type 1 diabetes (formerly known as "childhood", "juvenile" or "insulin- dependent"
diabetes) is not exclusively a childhood problem; the adult incidence of type 1 is
noteworthy many adults who contract type 1 diabetes are misdiagnosed with type 2
due to confusion on this point. There is currently no clinically useful preventive
measure against developing type 1 diabetes, though a vaccine has been proposed and
anti-antibody approaches are also being investigated. Most people who develop type 1
were otherwise healthy and of a healthy weight on onset, but they can lose weight
quickly and dangerously, if not promptly diagnosed. Although the cause of type 1
diabetes is still not fully understood, and diet and exercise may help, the immune
system damage is characteristic of type 1.
The most definite laboratory test to distinguish type 1 from type 2
diabetes is the C-peptide assay, which is a measure of endogenous insulin production
since external insulin has not (to date) included C-peptide. The presence of anti- islet
antibodies (to Glutamic Acid Decarboxylase, Insulinoma Associated Peptide-2 or
insulin), or lack of insulin resistance, determined by a glucose tolerance test, would also
be suggestive of type 1. Many type 2 diabetics continue to produce insulin internally,
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for Sick Children published research that shows a link between type 1 diabetes and the
immune and nervous system.
Using mice, the researchers discovered that a control circuit exists between insulinproducing cells and their associated sensory (pain-related) nerves. It's being suggested
that faulty nerves in the pancreas could be a cause of type 1 diabetes. control circuit
exists between insulin-producing cells and their associated sensory (pain-related) nerves.
It's being suggested that faulty nerves in the pancreas could be a cause of type 1 diabetes.
Inhe ritance
Type 1 Diabetes is a polygenic disease, meaning many different genes
contribute to its expression. Depending on locus or combination of loci, it can be
dominant, recessive, or somewhere in between. The strongest gene, IDDM1, is located
in the MHC Class II region on chromosome 6, at staining region 6p21. This is believed
to be responsible for the histocompatibility disorder characteristic of type 1: Insulinproducing pancreas cells (beta cells) display improper antigens to T Cells. This
eventually leads to the production of antibodies that attack these beta cells. Weaker
genes are also located on chromosomes 11 and 18. Environmental factors can strongly
influence expression of type 1. A study showed that for identical twins, when one twin
had type 1 diabetes, the other twin only had type 1 30-50% of the time. Despite having
the exact same genome, one twin had the disease, where the other did not; this shows
that environmental factors, in addition to genetic factors, can influence disease
prevalence.
Treatment
Type 1 is treated with insulin replacement therapy usually by injection
or insulin pump, along with attention to dietary management, typically including
carbohydrate tracking, and careful monitoring of blood glucose levels using Glucose
meters. Today the most common insulins are produced using genetic recombination
techniques; formerly, cattle or pig insulin were used, and even sometimes insulin from
fish. Major suppliers include Eli Lilly and Company, Novo-Nordisk, and SanofiAventis. A more recent trend, from several suppliers, is insulin analogs which are
slightly modified insulin are which have different onset of action times or duration of
action times. Untreated type 1 diabetes commonly leads to coma, often from diabetic
ketoacidosis, which is fatal if untreated. At present, insulin treatment must be continued
for life; this may perhaps change if better treatment, or a cure, becomes clinically
available. Continuous glucose monitors have been developed and marketed which can
alert patients to the presence of dangerously high or low blood sugar levels, but the
general lack of widespread insurance coverage (certainly in the US) and technical
limitations has limited the impact these devices have had on clinical practice so far.
In more extreme cases, a pancreas transplant can restore proper glucose regulation.
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have type 1. The fraction of type 1 in other parts of the world differs; this is likely due
to both differences in the rate of type 1 and differences in the rate of other types, most
prominently type 2. Most of this difference is not currently understood. Variable criteria
for categorizing diabetes types may play a part.
Cure
As of 2009, there is no known cure for diabetes mellitus type 1 in
modern clinical use. Pancreas transplant is not practical (too few are available, and
pancreas transplant is technically difficult. The requirement for immuno- suppressive
drugs contributes to the unsatisfactory nature of pancreas transplant as a cure). Nor is a
cure known from any other source including traditional or alternative medical practice.
There is ongoing research on various approaches to curing diabetes type 1.
Diabetes type 1 is caused by the destruction of enough beta cells to produce symptoms;
these cells, which are found in the Islets of Langerhans in the pancreas, produce and
secrete insulin, the single hormone responsible for allowing glucose to enter from the
blood into cells (in addition to the hormone amylin, another hormone required for
glucose homeostasis).
Hence, the phrase "curing diabetes type 1" means "causing a maintenance or restoration
of the endogenous ability of the body to produce insulin in response
to the level of blood glucose" and cooperative operation with counter regulatory
hormones.
This section deals only with approaches for curing the underlying
condition of diabetes type 1, by enabling the body to endogenously, in vivo, produce
insulin in response to the level of blood glucose. It does not cover other approaches,
such as, for instance, closed-loop integrated glucometer/insulin pump products, whic h
could potentially increase the quality-of- life for some who have diabetes type 1, and
may by some be termed "artificial pancreas".
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Reversion
Encapsulation approach
This islet sheet design consists of an inner mesh of fibers to provide strength for the
islet sheet; islet cells, encapsulated to avoid triggering a proliferating immune
response, adhered to the mesh fibers; a semi-permeable protective layer around the
sheet, to allow the diffusion of nutrients and secreted hormones; a protective coating,
to prevent a foreign body response resulting in a fibrotic reaction which walls off the
sheet and causes failure of the islet cells. Islet sheet with encapsulation research is
pressing forward with large animal studies at the present, with plans for human
clinical trials within a few years.
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Gene therapy:
Designing a viral vector to deliberately infect cells with DNA to carry on
the viral production of insulin in response to the blood sugar level. Technology for gene
therapy is advancing rapidly such that there are multiple pathways possible to support
endocrine function, with potential to practically cure diabetes. Gene therapy can be used
to manufacture insulin directly: an oral medication, consisting of viral vectors
containing the insulin sequence, is digested and delivers its genes to the upper
intestines. Those intestinal cells will then behave like any viral infected cell, and will
reproduce the insulin protein. The virus can be controlled to infect only the cells which
respond to the presence of glucose, such that insulin is produced only in the presence of
high glucose levels. Due to the limited numbers of vectors delivered, very few
intestinal cells would actually be impacted and would die off naturally in a few
days. Therefore by varying the amount of oral medication used, the amount of insulin
created by gene therapy can be increased or decreased as needed. As the insulin
producing intestinal cells die off, they are boosted by additional oral medications.
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Gene therapy might eventually be used to cure the cause of beta cell destruction,
thereby curing the new diabetes patient before the beta cell destruction is complete and
irreversible.
Gene therapy can be used to turn duodenum cells and duodenum adult
stem cells into beta cells which produce insulin and amylin naturally. By delivering beta
cell DNA to the intestine cells in the duodenum, a few intestine cells will turn into beta
cells and subsequently adult stem cells will develop into beta cells. This makes the
supply of beta cellsin the duodenum self replenishing, and the beta cells will produce
insulin in proportional response to carbohydrates consumed.
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Prevention:
"Immunization" approach:
If a biochemical mechanism can be found that prevents the immune
system from attacking beta cells, it may be administered to prevent commencement of
diabetes type 1. Several groups are trying to achieve this by causing the activation
state of the immune system to change from Th1 state (attack by killer T Cells) to
Th2 state (development of new antibodies). This Th1-Th2 shift occurs via a change in
the type of cytokine signaling molecules being released by regulatory T-cells. Instead
of pro- inflammatory cytokines, the regulatory T-cells begin to release cytokines that
inhibit inflammation. This phenomenon is commonly known as "acquired immune
tolerance".
2) Type 2 diabetes:
Diabetes mellitus type 2 or type 2 diabetes (formerly called noninsulindependent diabetes mellitus (NIDDM), or adult-onset diabetes) is a metabolic disorder
that is characterized by high blood glucose in the context of insulin resistance and
relative insulin deficiency. While it is often initially managed by increasing exercise
and dietary modification, medications are typically needed as the disorder progresses.
There are an estimated 23.6 million people in the U.S. (7.8% of the population) with
diabetes with 17.9 million being diagnosed, 90% of whom are type 2. With prevalence
rates doubling between 1990 and 2005, CDC has characterized the increase as an
epidemic. Traditionally considered a disorder of adults, type 2 diabetes is increasingly
diagnosed in children in parallel to rising obesity rates.
Unlike type 1 diabetes, there is little tendency toward ketoacidosis in type 2 diabetes,
though it is not unknown. One effect that can occur is nonketonic hyperglycemia which
also is quite dangerous, though it must be treated very differently. Complex and
multifactorial metabolic changes very often lead to damage and function impairment of
many organs, most importantly the cardiovascular system in both types. This leads to
substantially increased morbidity and mortality in both type 1 and type 2 patients, but
the two haven quite different origins and treatments despite the similarity in
complication
Pathophysiology:
insulin levels, as insulin controls this function in liver cells) decreased insulin- mediated
glucose transport in (primarily) muscle and adipose tissues (receptor and post-receptor
defects) impaired beta-cell functionloss of early phase of insulin release in response
to hyperglycemic stimuli Cancer survivors who received allogenic Hematopoietic Cell
Transplantation (HCT) are 3.65 times more likely to report type 2 diabetes than their
siblings. Total body irradiation (TBI) is also associated with a higher risk of developing
diabetes.
This is a more complex problem than type 1, but is sometimes easier to treat, especially
in the early years when insulin is often still being produced internally. Type 2 may go
unnoticed for years before diagnosis, since symptoms are typically milder (e.g., no
ketoacidosis, coma, etc) and can be sporadic. However, severe complications can result
from improperly managed type 2 diabetes, including renal failure, blindness, slow
healing wounds (including surgical incisions), and arterial disorder, including coronary
artery disorder. The onset of type 2 has been most common in middle age and later life,
although it is being more frequently seen in adolescents and young adults due to an
increase in screening programs. A type of diabetes called MODY is occasionally also
seen in adolescents, but this is classified as diabetes due to a specific cause and not as
type 2 diabetes.
Diabetes mellitus type 2 is presently of unknown etiology (i.e.,
origin). Diabetes mellitus with a known etiology, such as secondary to other
disorders, known gene defects, trauma or surgery, or the effects of drugs, is more
appropriately called secondary diabetes mellitus or diabetes due to a specific cause.
Examples include diabetes mellitus such as MODY or those caused by
hemochromatosis, pancreatic insufficiencies, or certain types of medications (e.g.
long-term steroid use).
The fraction of type 2 diabetics in other parts of the world varies substantially, almost
certainly for environmental and lifestyle reasons, though these are not known in detail.
Diabetes affects over 150 million people worldwide and this number
is expected to double by 2025. There is also a strong inheritable genetic connection in
type 2 diabetes: having relatives (especially first degree) with type 2 increases risks of
developing type 2 diabetes very substantially. In addition, there is also a mutation to
the Islet Amyloidal Polypeptide gene that results in an earlier onset, more severe, for m
of diabetes. About 55 percent of type 2 are obese chronic obesity leads to increased
insulin resistance that can develop into diabetes, most likely because adipose tissue
(especially that in the abdomen around internal organs) is a (recently identified) source
of several chemical signals to other tissues (hormones and cytokines). Other research
shows that type 2 diabetes causes obesity as an effect of the changes in metabolism
and other deranged cell behavior attendant on insulin resistance. Diabetes mellitus
type 2 is often associated with obesity, hypertension, elevated cholesterol (combined
hyperlipidemia), and with the condition often termed Metabolic syndrome (it is also
known as Syndrome X, Reavan's syndrome, or CHAOS). It is also associated with
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Diagnosis
The World Health Organization definition of diabetes is for a single
raised glucose reading with symptoms otherwise raised values on two occasions, of
either: fasting plasma glucose 7.0 mmol/l (126 mg/dl)or With a Glucose tolerance
test, two hours after the oral dose a plasma glucose 11.1 mmol/l (200 mg/dl)
Screening and prevention
Prevention
Onset of type 2 diabetes can often be delayed through proper
nutrition and regular exercise. Interest has arisen in preventing diabetes due to
research on the benefits of treating patients before overt diabetes. Although the U.S.
Preventive Services Task Force concluded that "the evidence is insufficient to
recommend for or against routinely screening asymptomatic adults for type 2
diabetes, impaired glucose tolerance, or impaired fasting glucose, this was a grade I
recommendation when published in 2003. However, the USPSTF does recommend
screening for diabetics in adults with hypertension or hyperlipidemia (grade B
recommendation).
In 2005, an evidence report by the Agency for Healthcare Research and
Quality concluded that "there is evidence that combined diet and exercise, as well as
drug therapy (metformin, acarbose), may be effective at preventing progression to DM
in IGT subjects".
Accuracy of tests for early detection
If a 2-hour post loads glucose level of at least 11.1 mmol/L ( 200 mg/dL) is used as
the reference standard, the fasting plasma glucose > 7.0 mmol/L
(126 mg/dL) diagnoses current diabetes with:
sensitivity about 50%
specificity greater than 95%
A random capillary blood glucose > 6.7 mmol/L (120 mg/dL) diagnoses
current diabetes with:
sensitivity = 75%
specificity = 88%
Glycosylated hemoglobin values that are elevated (over 5%), but not in the diabetic
range (not over 7.0%) are predictive of subsequent clinical diabetes in US female
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health professionals. In this study, 177 of 1061 patients with glycosylated hemoglobin
value less than 6% became diabetic within 5 years compared to 282 of 26281 patients
with a glycosylated hemoglobin value of
6.0% or more. This equates to a glycosylated hemoglobin value of 6.0% or more
having:
sensitivity = 16.7%
specificity = 98.9%
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Treatment:
Diabetes mellitus type 2 is a chronic, NON-progressive disorder that
has no established cure, but does have well-established treatments which can delay or
prevent entirely the formerly inevitable consequences of the condition. Often, the
disorder is viewed as progressive since poor management of blood sugar leads to a
myriad of steadily worsening complications. However, if blood sugar is properly
maintained, then the disorder is effectively cured - that is, patients are at no heightened
risk for neuropathy, blindness, or any other high blood sugar complication. There are
two main goals of treatment:
1. reduction of mortality and concomitant morbidity (from assorted diabetic
complications)
2. preservation of quality of life
The first goal can be achieved through close glycemic control (i.e., to
near 'normal' blood glucose levels); the reduction in severity of diabetic side effects has
been very well demonstrated in several large clinical trials and is established beyond
controversy. The second goal is often addressed (in developed countries) by support and
care from teams of diabetic health workers (usually physician, PA, nurse, dietitian or a
certified diabetic educator). Endocrinologists, family practitioners, and general
internists are the physician specialties most likely to treat people with diabetes.
Knowledgeable patient participation is vital to clinical success, and so patient education
is a crucial aspect of this effort. Type 2 is initially treated by adjustments in diet and
exercise, and by weight loss, most especially in obese patients. The amount of weight
loss which improves the clinical picture is sometimes modest (2-5 kg or 4.4-11 lb); this
is almost certainly due to currently poorly understood aspects of fat tissue activity, for
instance chemical signaling. In many cases, such initial efforts can substantially restore
insulin sensitivity. In some cases strict diet can adequately control the glycemic levels.
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Treatment goals
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Oral drugs:
A systematic review of randomized controlled trials found that
metformin and second-generation sulfonylureas are the preferred choices for most
with type 2 diabetes, especially those early in the course of the disorder. Failure o f
response after a time is not unknown with most of these agents: the initial choice o f
anti-diabetic drug has been compared in a randomized controlled trial which found
"cumulative incidence of monotherapy failure at 5 years to be 15% with rosiglitazone,
21% with metformin, and 34% with glyburide". Of these, rosiglitazone users showed
more weight gain and edema than did non-users.
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ACE inhibitors
The HOPE study suggests that diabetics should be treated with ACE inhibitors
(specifically ramipril 10 mg/d) if they have one of the following:
Hypertension hypercholesterolemia or reduced low high-density lipoprotein
cholesterol levels cigarette smoking microalbuminuria. After treatment with
ramipril for 5 years the number needed to treat was 50 patients to prevent one
cardiovascular death. Other ACE inhibitors may not be as effective.
3) Gestational Diabetes
Gestational diabetes is a form of diabetes which affects
pregnant women. It is believed that the hormones produced during pregnancy reduce
a woman's receptivity to insulin, leading to high blood sugar levels. Gestational
diabetes affects about 4% of all pregnant women. It is estimated that about 135,000
cases of gestational diabetes arise in the United States each year.
Hormones involved in development of placenta, which helps the
baby to develop also blocks, the action of the mother's insulin in her body. This
problem is called insulin resistance. During pregnancy a mother may need up to
three times more insulin for glucose to leave the blood and transform to energy.
When body is not able to use insulin due to insulin resistance it develops into
Gestational Diabetes. Glucose builds up in the blood to high level, it is called
hyperglycemia. Gestational diabetes affects the mother in late pregnancy and the
baby too. Insulin does not cross the placenta, as glucose and other nutrients do.
Extra blood glucose passes through the placenta that gives the baby a high blood
glucose level. It results the baby's pancreas to make extra insulin to get rid of the
blood glucose. Since the baby is getting more energy than it needs to develop and
grow, the extra energy is stored as fat.
It can lead to Macrosomia i.e. Fat baby. At birth this fat baby develops
problem in breathing or may develop hypoglycemia due to over production of
insulin.
Causes of Diabetes
The precise Etiology of most cases of diabetes is uncertain, although
certain contributing factors are as follows:
Type 1 diabetes
Type 1 Diabetes is autoimmune disorder that affects 0.3% on average. It is result o f
destruction of beta cells due to aggressive nature of cells present in the body.
Researchers believe that some of the Etiology and Risk factors which may trigger
type 1 diabetes may be genetic, poor diet (malnutrition) and environment (virus
affecting pancreas).
Secondly, in most of the cases, diabetes occurs because there is abnormal secretio n
of some hormones in blood which act as antagonists to insulin. Example :
Adrenocortical hormone, Adrenaline hormone and Thyroid hormone.
Type 2 diabetes
Type 2 Diabetes is also called non insulin-dependent diabetes mellitus (NIDDM) or
adult-onset diabetes. It occurs when the body produces enough insulin but cannot
utilize it effectively. This type of diabetes usually develops in middle age. A general
observation says that about 90-95 % of
people suffering with diabetes are type 2; about 80 percent are overweight. It is more
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common among people who are older; obese; have a family history of diabetes; have
had gestational diabetes. There are number of risk factors found to be responsible for
type 2 diabetes like, the more the Etiology and Risk factors carried by an individual, he
higher the risk for developing diabetes.
Following are the Causes of Diabetes
Hereditary or Inherited Traits :
It is strongly believed that due to some genes which pass from one generation to
another, a person can inherit diabetes. It depends upon closeness of blood relationship as
mother is diabetic, the risk is 2 to 3%, father is diabetic, the risk is more than the
previous case and if both the parents are diabetic, the child has much greater risk for
diabetes.
Age:
Increased age is a factor which gives more possibility than in younger age. This
disorder may occur at any age, but 80% of cases occur after 50 year, incidences
increase with the age factor.
Poor Diet (Malnutrition Related Diabetes) :
Improper nutrition, low protein and fiber intake, high intake of refined products are
the expected reasons for developing diabetes.
Obesity and Fat Distribution:
Being overweight means increased insulin resistance that is if body fat is more than
30%, BMI 25+, waist grith 35 inches in women or 40 inches in males.
Sedentary Lifestyle:
People with sedentary lifestyle are more prone to diabetes, when compared to those
who exercise thrice a week, are at low risk of falling prey to diabetes.
Stress:
Either physical injury or emotional disturbance is frequently blamed as the initial
cause of the disorder. Any disturbance in Cortiosteroid or ACTH therapy may lead
to clinical signs of the disorder.
Drug Induced:
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1. Frequent urination:
If you feel that you are needing to urinate more often than usual or a
compelling urge to urinate, along with discomfort in your bladder.
2. Excessive thirst:
The urge to drink too much beyond a certain limit may be a symptom of high
blood sugar in your bloodstream, and can be an important clue in detecting
diabetes.
3. Increase appetite:
If you are experiencing the drive to eat excessively due to emotional and
physical causes then it is an emotion disorder that compels you to eat even after you
are full. Increased appetite can be an early symptom of diabetes.
4. Unexplained weight loss:
Loss of body weight can occur due to various conditions ranging from eating disorders
to severe metabolic conditions including diabetes. Drastic weight loss of more than 5
to 10 pounds when you're not trying to requires medical attention because it may be a
sign of diabetes.
5. Blurry vision:
This is a symptom of great concern. If the blood sugar levels are too high, sugar builds
up in your eye, this excess sugar also draws in fluid, changing the shape of the lens and
making blurry vision. Certain types of blurry vision can be a medical emergency where
delay can lead to loss of sight.
6. Increased fatigue:
Unlike the tiredness experienced by a healthy person, sudden increase of fatigue
is a bad thing in people with symptoms of diabetes.
Most Type II diabetes is caused by uncontrolled diets that are high in saturated
fat. In the case of the cells of the pancreas dying off, experts believe it is caused
by excessive drinking of alcohol.
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Diabetic Care
Diabetes can be a tough disorder to handle. There are many reasons for it, firstly,
causes of the disorder are not clearly known, it is difficult to prevent. Secondly, once
you get the disorder, it is not possible to cure the same and
you need to take care of your health for entire life. This task can be quite daunting;
here are a few tips.
Diabetic Care Tips
If you have diabetes, you need to take some precautions, in your day
to day life as well and not only at those times, when you feel sick. Here are some
precautions that you can take in your everyday life:
You should monitor your blood glucose level regularly. Depending on the severity of
your condition, your doctor would tell you about the intervals, in which you should take
the test. You should take regular doses of medicine or insulin, as have been prescribed.
Regular exercise proves to be useful in controlling glucose levels.
However, you should avoid few exercises, that are known to cause further complications
like cardiovascular disorders, hypoglycemia etc. In case your glucose level drops
suddenly during or after exercise, you should consume a fruit juice or some similar
drink that provides you with sugar. Weight reduction is a key of success in managing
diabetes; hence take all the measures of carb control, what you can. In case you are
suffering from any ailment like flu, cold or any other disorder or infection, some extra
precautions need to be taken, to avoid further complications by diabetes:
Check your blood sugar level more frequently, to ensure that no harm is being caused
by diabetes. The illness may force some changes in your diet; consult your
doctor/endocrinologist about the changes you need to make in your diabetes medicine
accordingly.
You should drink lots of water and other clear liquids. Remember not to cut yourself
completely from food even if you are not experiencing hunger. Consult the doctor, if
you feel abnormal in any manner. For example you may be feeling excessively sleepy,
giddy, may have trouble with urination etc.
Even though diabetes is a chronic condition, the same does not mean, that you will
have to avoid every activity you enjoy, once you contract it. You can have the same
amount of fun, provided, that you take certain precautions. Remember, if you have
diabetes, you cannot ignore the precautions, nor do you need to get bogged down
completely by them.
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Diabetes Care
Eat food at fixed hours
Do not overeat
Do not eat immediately after a workout
Make sure you have three proper meals & light snacks in between
Eat about the same amounts of food each day
Eat your meals and snacks at about the same times each day
Make sure the gaps between your meals are short
Do not eat fast; masticate and munch your food well before you swallow
Drink a lot of water that will help flush the toxins off your system
Avoid fried foods and sweetmeats
Include fresh vegetable salad in every meal
Include sprouts in the diet
Take your medicines at the same times each day
Exercise at about the same times each day
Avoid smoking. Smoking leads to heart disorder and poor circulation Check
your feet for cuts, blisters,
and swelling which are likely to result from diabetes-related nerve damage
Try to stick up to the plan made up for sugar control
Check the other tests such as kidney function, liver function, heart function,
ketone level etc
Check your weight periodically and maintain ideal body weight
Diabetes Diet
Diet plays a significant role in controlling the diabetes. The
diabetic diet may be used alone or else in combination with insulin doses or with
oral hypoglycemic drugs. Main objective of diabetic diet is to maintain ideal
body weight, by providing adequate nutrition along with normal blood sugar
levels in blood. The diet plan for a diabetic is based on height, weight, age, sex,
physical activity and nature of diabetes. While planning diet, the dietician has to
consider complications such as high blood pressure, high cholesterol levels. With
respect to the above factors, a dietician will assess calories to be given, like
scheming the carbohydrates, proteins, fats, type of carbohydrate, amount of fiber
and so on. Exchange meal plan is a diet program which balances the amount of
carbohydrate that we intake per day. Glucose is a sugar released from
carbohydrate so, if we want to control blood sugar we have to limit the
consumption of simple carbohydrate.
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your blood sugar levels, the most commonly used method of obtaining a blood sample
is to prick the finger. You then take the blood that is released and put it onto a testing
strip, which comes with blood sugar level testing kits. This strip is then put into a
measuring device, and processed for around 30 seconds before a result is achieved.
But there is some good news!
Lots of research is on going and a new gadget is now available that checks a diabetics
blood sugar and lets them know if it falls to a dangerous low. Researchers have been
searching for the gadget for years. Monitoring devices are now coming on the market
and by late summer will be available in the United States.
These monitors are not as accurate as "normal" blood tests, finger
lances, but researchers are hoping that within a couple of years it will allow a diabetic
to forgo putting their finger to test for blood glucose levels. If the monitor signals that
blood sugar levels are low, it is necessary to take a blood test for confirmation. The
monitors are also slow to show rapid changes that occur, especially when you
exercise.
This monitor is working to make finger lances outdated for all diabetics. Those
who have used the monitors report little discomfort. A patch worn on the abdomen
may hurt when it goes on because there is a tiny wire placed under the skin to
measure the glucose in cell fluid. Once the patch is on, it is comfortable to wear and
sends information to a receiver. The receiver is about the size of a cell phone.
Researchers are working toward pairing the new monitoring device
to insulin pumps. These pumps have been on the market for years and could reduce
the time needed for controlling diabetes to a minimum. One such product has already
been approved in last year in April and is now offered for sale now.
The monitoring portion of the device will be available until later this summer, so it
isn't fully automatic yet, but it is promising news for those who are trying to contro l
Type 1 or Type 2 diabetes.
Another new treatment going through trials is the delivery of insulin through
inhalation. The insulin is prepared in a dry micro fine powder form which is inhaled
directly into the lungs from where it is absorbed into the blood stream.
Diagnosis
Diabetes is suspected based on symptoms. Urine tests and blood tests
can be used to confirm a diagnose of diabetes based on the amount of glucose in the
urine and blood. Urine tests can also detect ketones and protein in the urine which may
help diagnose diabetes and assess how well the kidneys are functioning. These tests
can also be used to monitor the disorder once the patient is on a standardized diet, oral
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medications, or insulin.
ten years. They can not be used with type I diabetes, or diabetes of pregnancy. They
can be safely used with metformin or -glitazones. The primary side effect is
hypoglycemia.
First- generation agents
o tolbutamide (Orinase)
o acetohexamide (Dymelor)
o tolazamide (Tolinase)
o chlorpropamide (Diabinese)
Second-generation agents
o glipizide (Glucotrol)
o glyburide (Diabeta, Micronase, Glynase)
o glimepiride (Amaryl)
o gliclazide (Diamicron)
Meglitinides
Meglitinides help the pancreas produce insulin and are often called
"short- acting secretagogues." Their mode of action is original, affecting potassium
channels. By closing the potassium channels of the pancreatic beta cells, they open
the calcium channels, hence enhancing insulin secretion.
They are taken with meals to boost the insulin response to each meal.
repaglinide (Prandin) - The maximum dosage is 16 mg/day, taken 0 to
30 minutes before meals. If a meal is skipped, the medication is also skipped.
nateglinide (Starlix) - The maximum dosage is 360 mg/day, usually
120 mg three times a day (TID). It also follows the same
recommendations as repaglinide.
Adverse reactions include weight gain and hypoglycemia.
Sensitizers
Biguanides
Biguanides reduce hepatic glucose output and increase uptake of
glucose by the periphery, including skeletal muscle. Although it must be used with
caution in patients with impaired liver or kidney function, metformin has become the
most commonly used agent for type 2 diabetes in children and teenagers.
Amongst common diabetic drugs, metformin, a biguanide, is the only widely used oral
drug that does not cause weight gain.
metformin (Glucophage). Metformin may be the best choice for patients
who also have heart failure.
phenformin (DBI): used from 1960s through 1980s, withdrawn due to lactic
acidosis risk.
buformin: also withdrawn due to lactic acidosis risk.
53
Alpha-glucosidase inhibitors
Alpha- glucosidase inhibitors are "diabetes pills" but not technically
hypoglycemic agents because they do not have a direct effect on insulin secretion or
sensitivity. These agents slow the digestion of starch in the small intestine, so that
glucose from the starch of a meal enters the bloodstream more slowly, and can be
matched more effectively by an impaired insulin response or sensitivity.
These agents are effective by themselves only in the earliest stages of impaired
glucose tolerance, but can be helpful in combination with other agents in type 2
diabetes.
54
miglitol (Glyset)
acarbose (Precose/Glucobay)
These medications are rarely used in the United States because of the severity
of their side effects (flatulence and bloating). They are more commonly
prescribed in Europe. They do have the potential to cause weight loss b y
lowering the amount of sugar metabolized.
Peptide analogs
Overview of insulin secretion
Incretin mimetics
Incretins are insulin secretagogues. The two main candidate molecules that fulfill
criteria for being an incretin are Glucagon- like peptide-1 (GLP-1) and Gastric
inhibitory peptide (aka glucose-dependent Insulinotropic peptide or GIP). Both GLP-1
and GIP are rapidly inactivated by the enzyme dipeptidyl peptidase-4 (DPP-4).
55
Amylin analogues
Amylin agonist analogues slow gastric emptying and suppress
glucagon. They have all the incretins actions except stimulation of insulin secretion. As
of 2007, pramlintide is the only clinically available amylin analogue. Like insulin, it is
administered by subcutaneous injection. The most frequent and severe adverse effect of
pramlintide is nausea, which occurs mostly at the beginning of treatment and gradually
reduces.
Experime ntal agents
Many other potential drugs are currently in investigation by pharmaceutical
companies. Some of these are simply newer members of one of the above classes, but
some work by novel mechanisms. For example, at least one compound that enhances
the sensitivity of glucokinase to rising glucose is in the stage of animal research. Others
are undergoing phase I/II studies.
PPAR/ ligands (muraglitazar and tesaglitazar - development stopped
due to adverse risk profile, aleglitazar - under clinical development) s
SGLT (sodium- dependent glucose transporter 1) inhibitors increase urinary
glucose. FBPase (fructose 1,6-bisphosphatase) inhibitors decrease
gluconeogenesis in the liver.
Herbal extracts
A recent review article presents the profiles of plants with
hypoglycaemic properties, reported in the literature from 1990 to 2000 and states that
"Medical plants play an important role in the management of diabetes mellitus
especially in developing countries where resources are meager."Animal studies have
found that walnut leaf and garlic can significantly reduce fasting blood glucose levels
in rats with alloxan- induced diabetes.
Myrcia
The first registered use of anti-diabetic drugs was as herbal extracts
used by Indians in the Amazon Basin for the treatment of type 2 diabetes, and today
promoted as vegetable insulin although not formally an analog. The major recent
development was done in Brazil around Myrcia sphaerocarpa and other Myrcia
species. "Many countries, especially in the developing world, have a long history of the
use of herbal remedies in diabetes (...) STZ diabetic rats were also used to test Myrcia
Uniflora extracts (...) ". The usual treatment is with concentrated (root) Myrcia extracts,
commercialized in a 4 US dollar per kilogram packed rocks (~100 times cheaper than
equivalent artificial drugs), named "Pedra hume de ka".
Phytochemical analysis of the Myrcia extracts reported kinds of flavanone glucosides
(myrciacitrins) and acetophenone glucosides (myrciaphenones), and inhibitory
56
1 tablespoon aloe vera gel. Take the mixture twice a day before lunch and dinner.
4. Take twice daily, with powder of rose apple stones (powder of Jambu or Jamun-kiGuthali).
5. Include decoctions of triphala, fenugreek, musta, arjuna, sandalwood, lodhra, ajwan,
gokshura, vidanga, guduchi, haritaki, and chitrak. These may be taken with a small
amount of ghee. Gudmar and shilajit are excellent.
6. Amalaki Churna (500mg), Haldi Powder (Turmeric Powder) 500mg and
Naag Bhasma (125mg) should be taken with honey, twice daily ( A 12- hourly
dose ).
Anti-diabetic spray
Diabetics, who are used to insulin shots, have a painless option a spray which can be delivered through the inner lining of the mouth. And the
pleasure of chewing an insulin bubble gum is not far off for them. Shreya Life
Sciences India, launched the Oral-Recosulin spray in. the product would be the
world's first recombinant DNA human insulin buccal spray effective against Type
I and Type II diabetes. Each pack of Oral- Recosulin will have 80 puffs equivalent
to per unit of injection. Each vial of insulin available in the market now consists
of 300 units of injection priced at a range of Rs 125 to Rs 1,000 but oral Recosulin will come at an approximate price of Rs 2,200 for a pack of two vials.
The drug has been developed by US-based Generex Biotechnology Corporation.
Shreya has entered into a product licensing and distribution agreement with
Generex to market the product in India. The new technology delivers insulin
through Buccal Mucosa directly to the vascular system and, thus, does not enter
the lungs. Hence, there would not be any side effects, Dr Jaime Davidson,
endocrinologist and medical director of Generex, said.
The next non- injectable insulin product of Generex would be 'metcontrol', a chewing
gum, Abajian said.
Yoga
Yogic exercises can help with diabetes. When practiced as part of a
daily yoga routine of breathing exercises, meditation and poses, these exercises
enhance digestion and help the pancreas and liver function more normally,
regulating blood sugar levels.
Yoga Asana Useful for Diabetes:
Sun Salutation
Peacock pose
Locust pose
Leg lift
Chest knee pose
58
59
60
Insulin Synthesis
Insulin is synthesized as a preprohormone in the beta cells of the islets of
Langerhans. Its signal peptide is removed in the cisternae of the endoplasmic reticulum
and then packaged into secretory vesicles in the Golgi. It is folded in its native
structure and locked in this conformation by, the formation of 2 disulfide bonds.
Insulin resistance
Insulin resistance comes in picture when the total amount of insulin
produced by the body (pancreas), proves to be insufficient to maintain normal blood
glucose level. Extra insulin may need to break down glucose in order to release
energy. In about 1/3 of the cases blood cells resist to even high level of insulin.
Insulin resistance is mostly associated with high Triglycerides and low HDL,
hypertension, cardiovascular disorder and other such abnormalities. It is in these
abnormalities that we find the insulin resistance syndrome. Few people sometimes
suffer from various symptoms and conditions. It is thus believed that diabetes and
other problems go hand in hand.
Types of Insulin
There are more than 20 types of insulin products available in four
basic forms, each with a different time of onset and duration of action. The decision
as to which insulin to choose is based on an individual's lifestyle, blood sugar level
and a physician's preference and experience. Criterions to be considered in choosing
insulin are:
Onset:- how soon it starts working. Peak
time:- when it works the hardest. Duration:how long it lasts in the body.
Insulin Regimens
Insulin regimen is the way that your insulin injections are organized
throughout the day. Type1 diabetics need more than one injection per day and use
more than one type of insulin. The combination of insulins and the number of times
you take your injections, frame your insulin regimen. There are numerous types of
insulin regimens. Ideally, you will develop an individualized regimen that fits in with
your life style.
Diabetes Insulin Classification
There are five different types of insulins ranging from short to
long acting. Some insulins are clear in appearance, while others are cloudy. Diabetics
61
need varying amounts of both short and long acting insulin as everyone is different
and will respond differently to the insulin they take. Lets see the classification of
different types of insulin.
Rapid onsetfast acting insulin: It is fast acting so starts working within one to 20
minutes. It is clear in appearance and its peak time is about one hour later and lasts for
three to five hours. When you inject rapid onset-fast acting type of insulin, you must
eat immediately after you inject. The two rapid onset-fast acting insulin types currently
available are:
Novo Rapid (Insulin Aspart)
Humalog (Lispro)
Short acting insulin: It looks clear and begins to lower blood glucose levels within 30
minutes, so you need to take your injection half an hour before eating. Short acting
insulin has peak effect of four hours and works for about six hours. Short acting insulin
types, currently available include:
Actrapid
Humulin
Hypurin Neutral (bovine - highly purified beef insulin)
Inte rmediate acting insulin:- Intermediate acting insulin looks cloudy. They have
either protamine or zinc added to delay their action. This insulin
starts to show its effect about 90 minutes after you inject, peak at 4 to 12 hours and
lasts for 16 to 24hours.
Intermediate acting insulins presently available with protamine:
Protaphane
Humulin NPH
Hypurin Isophane (bovine)
Mixed insulin: Mixed insulin is cloudy in appearance. It is a combination of either a
rapid onset- fast acting or a short acting insulin and intermediate acting insulin.
Advantage of it is that, two types of insulin can be given in one injection. When it
shows 30/70 then it means 30% of short acting is mixed with 70%of intermediate
acting insulin.
The mixed insulins currently available include:
NovoMix30
Humalog Mix 25
Mixtard 30/70
Mixtard 20/80
62
Long acting insulin: There are two kinds of long acting insulin available in market,
both with clear appearance.
Lantus (Glargine) - It has no peak period as it works constantly when released
into your bloodstream at a relatively constant rate. (full 24 hours)
Levemir (Detemir) - It has a relatively flat action, can last up to 24
hours and may be given once or twice during the day.
Diabetes Prevention
Prevention is proven to be one of the most effective and powerful
methods to fight diabetes. More than 50% of diabetes is caused due to inappropriate
lifestyle. Regulating lifestyle can prove to be advantageous in downfall of probability
of contracting diabetes in ones life. Loss of weight not only helps in fitness but also
in control of blood sugar levels. Losing 10% of initial body weight and regular
exercise can immensely reduce the risk of diabetes. Physical activities play a key role
in reducing the body weight and on the other also the extra blood sugar is broken
down. It also helps to uphold the blood sugar in the normal range. You are more
liable to diabetes if you are overweight (may also lead to obesity), are having genetic
or hierarchal means of predisposition along with proper physical activity.
Food choices: Foodstuffs containing low glycemic carbohydrates, proteins or fats can
initially help to lose body weight and maintain dancing blood sugar level. Prefer
healthy foods which are low in fats and calories such as lean fish, lean chicken, turkey
and fruits and vegetables. Go slow on fast and fried foodstuffs for prevention of
diabetes. Avoid processed carbohydrates as much as possible. Try to increase highprotein food in your diet. And reduce eating refined flour i.e. white flour, bleached
flour, treated flour and other kind of white flour.
The Fundamentals to prevent diabetes: Diabetes can be prevented by good production
of the insulin and keeping the body fat percent low. Insulin and fats helps to maintain
body weight and control sugar level. Consumption of meals to a small fraction instead
of heavy food also helps to control diabetes. Also avoid eating carbohydrates few
hours before you go to sleep. Taking in high-protein breakfast and 5 or 6 small meals
a day also helps you to maintain the body weight. This will also help to control excess
consumption of fats and carbohydrates.
Diabetes Complications:Once we have crossed the reversible stage of prediabetes and enter
diabetes stage, certain changes start developing in our body. These changes occur due
to high blood sugar level with instability in the hormones as well as blood vessels and
nerves. When these changes become permanent in the body it develops into serious
Diabetes Complications and body indicates these changes by steady symptoms.
63
65
66
Sales (Crores)
March 2008
% of sales
Category
Ant diabetic
1600
value growth
27.2
6%
Anti- infective
5730
15.2
20%
Cardiac
3480
23.4
12%
Derma
1750
12.6
6%
Gastrointestinal
3500
14.1
13%
Gynaec
1810
18.9
6%
Neuro
1760
16.6
6%
Pain
2840
8.2
10%
Respiratory
2880
11.6
10%
Vitamins
2630
9.8
9%
Total
27980
14.8
100%
Lifestyle segment
Lifestyle segment which includes anti-diabetic, cardiac and gastrointestinal have registered a growth of more than 20% during the year. The total
lifestyle segment contributed to around 31% in the therapeutic category as on March
2008. In 2015, the anti-diabetic market in India is expected to grow at a CAGR of
17.02% to Rs.84 billion and the cardiac market is expected to grow at 12.40% to
Rs.143 billion in sales. India has the worlds largest diabetic population, constituting
20 percent of the worlds diabetic population.
India, industry sources expect this to at least double in the coming year. A study by
Decision Resources, a research-based consulting organization, shows that the
prevalence of type 2 diabetes in India is among the highest in the world with more than
28 million cases in 2007. The prevalence of type 2 diabetes is expected to grow more
rapidly in India than in any other nation, climbing to more than 60 million cases by
2017. Type 2 diabetes is the most common form of diabetes. In type 2 diabetes, either
the body does not produce enough insulin or the cells ignore the insulin.
WHOs Burden of Disorder report states that diabetes is going to
grow by 40% in developed countries, but by 170% in developing countries. Apart fro m
this rise, there are so many undiagnosed people, said International Diabetes
Federation vice-president SM Sadikot. A study by Mr Sadikot has shown that by 2030,
the number of rural people suffering from diabetes will equal those in urban areas.
Oral diabetic medication generated revenues of Rs 1,183 crore in the last year while
insulin posted sales of Rs 511 crore, according to an ORG-IMS report. The top players
in this segment include Abbott, USV, Sanofi Aventis, Sun Pharma, Nicholas Piramal
and Wockhardt.
The number of companies looking to enter this therapeutic area is also on
the rise. Lots of companies are looking at entering the chronic
illness space. With a slowing down of acute illnesses in larger cities and towns and
the change in lifestyles, companies who have a presence in anti- infectives are also
entering the anti-diabetic space, said Alok Dalal, analyst with Religare.
Trying to break into the chronic illness segment is easier when compared to CNS
(central nervous system) segment, he added. Piramals shift in focus from acute to
chronic is a case in point. Lots of companies are working on molecules for diabetes
and we should see a new molecule out in a couple of years. As far as MNCs go, GSK
will probably be the leader in launching a molecule.
Decision Resources report forecasts that the Indian type 2
diabetes drug market will double from $504 million in 2007 to more than $1.1
billion by 2012. This potential has not gone unnoticed by the industry and Indian
companies are not the only ones looking at this segment as a lucrative market.
European companies are also looking at entering this segment either through
collaborations or formal dialogue between governments. The UK is the first to have
taken a step in this direction. There are 180 million diabetic people in the world
today and India accounts for 27% of that. We plan on working with different
organizations and countries to combat this, India being one of them, said Ann
Keen, UK under secretary of state for health, at a diabetes conference in Mumbai
last three month before. Sujay Shetty, associate director at PricewaterhouseCoopers,
said, Chronic disorders like diabetes are going to be a big market going forward.
This segments contribution to the overall pharmaceutical market is going to
increase.
68
Market Metrics
Diabetes is estimated to account for 23% of annual pharmacy store
revenues in the U.S. The largest diabetes care market by a wide margin is the United
States, which, at close to $7 billion in 2002, was well over five times larger than
second-ranked Japan. Again, the World Health Organization (WHO) estimates that
almost 180 million people worldwide are afflicted with diabetes. This number is
expected to more than double by 2030. In 2005, an estimated 1.1 million people died
from Type 1 diabetes. Almost 80% of diabetes deaths occurred in low and middleincome countries and almost half of diabetes deaths occurred in people under the age
of 70 years. Women account for 55% of deaths associated with diabetes.
The global market fro a diabetes drug was valued at US $15 billion in
2005. Oral anti-diabetics were the chief class of drugs - $8.19 billion - and showed a
growth rate of 6.3% over 2004. Total sales for insulin products increased by 16.5% to
total global sales of $6.83 billion in 2004.
69
< works it
Disadvantage s
Drug Category
Generic
Alpha-
Name
Glyset,
glucosidase
Meglitinides
it
Advantages
Blocks the
Lowers
Precose
absorption of
some
carbohydrate s
in the intestine
Glucophag
Helps the
Does not
Can't take if
cause
low
blood
glucose, may
help
with
weight
loss and can
improve
blood lipids
(fats).
you
drink
alcohol
excessively.
Can
cause
nausea
and
diarrhea
when started.
Prandin
Reduces
Rapidly
Can cause
blood
glucose
absorbed
the body.
Inhibitors
Biguanides
How>How
works
May cause
by
blood glucose
to get too
70
levels by
Can be used
stimulating
insulin release
form
the
pancreas.
alone
or
with
metformin.
low.
Thiazolidinedio
Actos,
Works to
Cannot
Can cause
Nes
Avandia
decrease
insulin
resistance
and improves
the
muscle's
ability to use
insulin. Does
not make more
insulin.
>
cause blood
glucose to get
too low if it is
the
only
diabetes pill
taken.
liver
problems.
Some birth
control pills
may
not
work.
Sulfonylureas
Diabeta,
Lowers blood
These are
Can cause
Glucotrol
glucose
by 2nd
blood glucose
helping
the generation
to get too
pancreas
drugs
with low.
produce more fewer
side
insulin.
effects tha n
older
sulfonylurea
s.
XL
Amaryl,
Micronase,
Glynase
Generic:
Glyburide,
Glipizide
71
Company
Year of Launch
Insulin
Huminsulin
1982
Insugen
Company India
Biocon
2004
Novo Nordisk
2003
Recosulin
2004
Wosulin
Wockhardt
2003
72
Diabetes care
Haemostasis management (NovoSeven
Hormone replacement therapy (HRT)
45,5
74
Eli Lilly
Eli Lilly launched Byetta, a new class of drug for Type B diabetics
and has plans to launch new products in the coming years.
Eli Lilly and Company (India) is a 100 percent subsidiary of the US pharmaceutical
major, Eli Lilly and Company. The company first came to India in 1993 as a JV with
Ranbaxy. It became a wholly owned subsidiary in 2001 when Lilly bought the 50
percent stake held by Ranbaxy and since then the company has established a
formidable presence in cardiology, diabetes and oncology amongst other therapeutic
segments. Lilly India has five products from the biotechnology stable. All injectibles,
they are human insulin (including human insulin analogs), human growth hormone,
Teriparatide (Forteo), Drotrecogin Alfa (Xigris) and Exenatide (Byetta). Overall,
diabetes care product range contributes roughly 60 percent of the Lilly India revenue.
In the biotech category, the company grew an impressive 20 percent in 2007 clocking
revenue of Rs 137 crore compared to Rs 114 crore in 2006. The company's recent
product launches include Byetta that was introduced in October 2007. The drug
belongs to a new category called "incretin mimetics" and is a unique treatment option
for Type 2 diabetics, more specifically for patients who have maxed out on the OHA's
(oral hypoglycemic agents). According to Sandeep Gupta, CMD, Lilly, "Byetta is a
first-in-class product. These are early days; however within 3-4 months from its
launch, nearly 1000 patients have been put on the therapy across India." Forteo, Lilly's
novel therapy that 'rebuilds' bones and is used for treating women with osteoporosis,
registered a whopping growth of almost 100 percent in 2007 as compared to the
previous year.
Lilly India recently tied up with an Ahmedabad-based Contract Sales
Organization (CSO), PharmaLink, to further enhance its reach in large towns while
maintaining adequate coverage in smaller markets. The company also divested its
premium antibiotic brand, Distaclor. This was done with a view to augment company
focus on its range of new products. Also in a global deal, the company entered into a
unique drug development agreement with Mumbai-based Nicholas Piramal India Ltd
(NPIL) in 2007. Under this partnership, Lilly has outlicensed a molecule for 'metabolic
disorder' o NPIL with an arrangement to do research till phase III and if the product is
found to show the desired potential.
Wockhardt
Wockhardt is a technology-driven global pharmaceutical and
biotechnology major with an innovative multi-disciplinary research and development
programme. It has 5 research centres and 15 world-class manufacturing plants dotting
various countries and continents that are compliant to international regulatory
standards such as the US FDA, MHRA or other global regulatory bodies. It has endto-end integrated capabilities for its products, starting with manufacture of the oral and
sterile APIs, the dosage forms and marketing through its wholly owned subsidiary in
the US. Wockhardt has a global footprint including the USA, UK, Ireland, France, and
75
in three cartridges was launched. Amaryl, which is an oral anti- diabetic, had a 4.4
percent share in the oral anti-diabetic market.
Aventis conducted a large observational study in 2007, with around
10,000 patients evaluating effect of the change of the insulin therapy in type 2
diabetes patients whose blood sugar was not under control with the existing insulin
therapy. The study involved 800 doctors. Also another observational study was
implemented with about 200 doctors to observe the management of myocardinal
infarction and usage of anti- thrombotics. Another observation study with Cardace was
implemented in which management of patients who are at high risk of cardiovascular
events in real life settings was evaluated.
Biocon
Market Research on Humins ulin-R:Now a days Diabetes is a common disorder in every country.
Thats the reason the anti-diabetic market is expanding or increasing day by day.
Now days Insulin is easily available in every country. Old aged people are suffered
more towards the diabetes. Day by day the number of patient is increasing. To seeing
the opportunity every company launching the anti- diabetic drug.
In India Eli Lilly have major market share in anti-diabetic market. They
have 60% market share, followed the Eli Lilly, Novo Nordisk India is the major
player in India. The major brand of Eli Lilly is Huminsulin (r) U100
79
Allergies
tell your doctor if you have ever had any unusual or allergic reaction to insulin
detemir. Also tell your doctor and pharmacist if you are allergic to any other
substances, such as foods, preservatives, or dyes.
Pregnancy
the amount of insulin or insulin detemir you need changes during pregnancy. It is
especially important for your health and your baby's health that your blood sugar be
closely controlled before you become pregnant and throughout pregnancy.
Breast-feeding
It is not known whether insulin detemir passes into human breast
milk. Although
most medicines, including human insulin, pass into breast milk in small amounts, many
of them may be used safely while breast-feeding.
Mothers who are taking this medicine and who wish to breast- feed should discuss this
with their doctor.
Children
Studies on this medicine have been done only in adult patients, and there is no specific
information comparing use of insulin in children with use in other age groups.
Older adultsthis medicine has been tested in a limited number of patients
65 years of age or older and has not been shown to cause different side effects or
problems in older people than it does in younger adults.
Other medicines
although certain medicines should not be used together at all, in other cases
two different medicines may be used together even if an
interaction might occur.
Possible Side effects with Huminsulin-R.
Many medications can cause side effects. A side effect is an unwanted
response to a medication when it is taken in normal doses. Side effects can be mild
or severe, temporary or permanent. The side effects listed below are not
experienced by everyone who takes this medication.
The following side effects have been reported by at least 1% of people taking
this medication. Many of these side effects can be managed, and some may go
away on their own over time. redness, itching, or swelling at the site of the
81
injection skin changes at injection site Stop taking the medication and seek
immediate medical attention if any of the following occur: rash or blisters all
over the body seizures symptoms of a serious allergic reaction (i.e., swelling of
face or throat, sudden sweating, vomiting, difficulty breathing, rapid heartbeat,
itchy skin rash, and dizziness) unconsciousness
70-80
10%
60-70
7%
20-30
20%
50-60
13%
30-40
23%
40-50
27%
The survey was perform on 50 doctors to know how much patients of diabees approach
to doctor in a month. The study showed that patients in the range of 20-30, 30-40,4050,50-60,60-70,70-80 approach were in percentage of 20, 23, 27, 13, 7, 10 respectively.
The communication with doctor during survey concluded that the number of patients
are increasing day by day.one of senior doctor told that initially diabetes was very less
as compared to present. it can be said that the diabetes is increasing in double ratio
specially in old age people.
Few doctors said that the main cause of diabetes is changing life style of the people.
again they gave more focus on city people who are working in night and day shift.
83
TOPIC: 2
The two type of diabetes patients approach to doctors.
0% 0%
IDD
50%
NIDD
50%
The survey from all doctor concluded that both type of diabetes patient i.e. non- insulin
dependent diabetes mellitus(NDDM) and insulin dependent diabetes mellitus (IDM) approach
to doctor. The approach of both type of diabetes was in near about in equal percentage. But the
communication with doctor in detail provided knowledge that IDDM is more in young people
and they said that the genetic factor is the main reason for this type of diabetes and NDDM
was more in old people and for this they told that the increase in resistance of insulin receptors
with more age.
84
TOPIC: 3
The survey from all doctors concluded that the diabetes is controllable
curable
0%
controllable
100%
After meeting to all doctors it come to known that the diabetes is only controllable i.e. only
management is possible but it can not be cure means no therapy or drug is available which can
permanently make patient free from diabetes. Patients has to regularly monitor glucose level
with glucometer like instruments. Diabetes patient also need to take lot of care in diet and the
medicine should be taken from time to time. The IDDM patient need to take regularly
subcutaneous injection of insulin. the missing of drug dose and carelessness in diet can lead to
threatening condition patient may need to hospitalized.
85
TOPIC: 4
The survey from all doctors about diabetes is a serious disorder-some said yes while
others said no and some come to conclusion that may or may not be.
YES & NO
20%
YES
43%
NO
37%
About 43% doctor said that diabetes is a serious disorder .for this they give reason that it is a
chronic illness and not curable, after many years diabetes patient suffers from many other
disorder like diabetic neuropathy, many times in severe case it happens that patient some body
part is need to cut. But about 37% doctors told that it is not a serious disorder. They concluded
that if patient is well educated and has taken lot of care to maintain diabetes he can live a happy
life. the few doctors about 20% said that it can be serious or not depends totally on patient
habit, nature and life style.
86
TOPIC: 5
All doctors said that Herbal drug, Exercise, Yoga help to control diabetes
No
0%
Yes
100%
The survey with all doctors help to understand that yoga, herbal drug, exercise control diabetes
and provide better health to diabetes patients. The 100% doctors have given positive response.
The regular yoga in morning has given relief to patients. The herbal formulation amla,
cinnamon, bitter gourd, jamun reduce the sugar level. The exercise like jogging etc has also
provided many benefits to patient.
87
TOPIC: 6
The survey from all doctors concluded that nutrition (diet) play important role to
control diabetes.
No
0%
Yes
100%
Yes, all doctors during survey said that nutrition play important role in control of diabetes.
The proper diet maintain the sugar level at normal level. The patient who has paid lot of
attention on nurtrition needs to take less medication and they also suffers from less side
effects of drug. The diabetic neuropathy, diabetic foot ulcer are very less observed in patient
who has taken care in nutrition.
The doctor also said that the fast food is also responsoible for increasing diabetes patients. So
they advice to take proper calorie food which is needed by patients.
88
TOPIC: 7
0%
NIDD
50%
IDD
50%
The doctor said that depending on type of diabetes drug therapy also need to give different.
They said that in case of IDD mostly subcutaneous injection of insulin is preffered like insulin
lispro, insulin glargline,protmine zinc insulin. While in case of NIDD doctors like to preffered
drug as well as insulin injection. but the diabetes can be controlled mostly by taking drug
tolbutamide, chlorpropmide, metformin, sitagliptin etc. regularly.
89
TOPIC: 8
The most doctors said that the cost of treatment is affordable to patient is not
sufficient while fe w come to conclusion it may or may not be.
YES
NO
BOTH
The statement made by doctors on whether cost of drug is affordable to patient is very
controversial. Some doctor said that it is affordable due to generic products are available in
market and lot of competitors are their for particular which are reducing the cost of drug.
While few said that the cost is not affordable for many patients and there is still need to
reduce the cost of drug. New drugs which are patented is of very high cost and it is not
affordable for many patients.while few doctors said tha t it is easy to pay the price of
diabetes drug but for many patients it is very difficult.
90
TOIPC: 9
60
50
40
30
20
10
0
yes
no
both
The 60% of doctor spoke that there are many side effects like vitamin deficiency, lactic
acidoisis, metallic taste, dryness of mouth, hypohlycemia.hupoglycemia side effect is very
serious it can put patient life in threatening situation. The near about 25% doctor said that there
is not that much side effect which can be neglected but there is only need to take proper dose
should be given to patiens according to situation. some said there are side effect depend on
patient physiology so few doctor said that side effect can be or not.
91
TOPIC: 10
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Metformin
Levemir
The survey concluded that all doctors know about both brands Huminsulin- R. They said brands
are most commonly prescribed. There is no hesitation in writing these brands. Brand have
given excellent result. The patient to whom this brands are prescribed they have given positive
response.
92
Sales
7
19
1 to 5
39
5 to 10
10 to 15
35
15 to 20
Inte rpretation:
Daily prescription rate of of Antidiabetic drugs is more in quantity as a result of this question
reply by the chemist is as antidiabetic prescribe by doctor is at the high rate. Average
prescription rate is 10 to 15 prescription daily.
93
Demand
32
Yes
68
No
Inte rpretation:
As the result come after the chemist response for the self prescribing by the patient is due to
the prescription repeating or the result of antidiabetic thus the data shows that the self
prescription of antidiabetic by the patient himself is much higher than the normal
prescription.
94
28
33
Doctors Rx
Low Price
Efficacy
39
Inte rpretation:
Patients purchase the specific brand due to the low price and as per the doctors prescription
and the patient has less perception of efficacy in mind while purchasing of the particular
antidiabetic brand
95
Reason
19
42
MR Influence
Direct Adv.
Low Price
39
Profit Earn
Inte rpretation:
Chemists keep stock of specific brand of antidiabetic due to the Medical Representative
influence them about the brand and secondary they kept due to the low price of the brand
96
Awareness
0
Yes
No
100
Inte rpretation:
During the survey the result has come to see that che mist is aware of the Huminsulin-R brand
of antidiabetic and they are well known of the efficacy and result of the Huminsulin- R.
97
Stock
21
Yes
No
79
Inte rpretation:
Most of the chemists are aware of the Huminsulin- R and they keep the stock of HuminsulinR and the amount of chemist which are not keep the stock of the Huminsulin- R due to their
specific reason which they dont want to disclosed during the survey.
98
Reason
13
35
MR Influence
Low Price
52
Margin of Profit
Inte rpretation:
According to the chemist response sales of the Huminsulin-R is due to the low price and
same where Medical Representative Influences and every few has response for the margin of
profit.
99
Preference
29
Yes
71
No
Inte rpretation:
According to the chemist response for the personal preference of Huminsulin- R has shown
the result as Approximately 80% of chemist are prefer Huminsulin-R personally and use the
Huminsulin- R. whereas remaining percentage of chemist doesnt pre fer it due to their
specific reason but many of the chemist personally prefer Huminsulin- R.
100
CONCLUSION
Now a days Diabetes is a very common disorder in India as well as through out the world.
Every fifth person is suffered by the diabetes disorder. India is an expanding stage in Antidiabetic market. In coming few years India is become the top position for diabetic
patient/Market. Currently US & Japan are the major market for diabetic drug. In India
diabetic care division is growing two digit growth nearly about 20% Growth rate. Antidiabetic segment covers 6% overall Pharma industry.
In India Eli Lilly is a market leader in Anti-diabetic drug having 60% share. Eli
Lilly is also world leader in Anti-diabetic drug. In India Novo Nordisk & Eli Lilly have
82% share in this segment.
From doctors perception about diabetes is not a serious disorder, but it affects
the individuals life. In diabetes there is no place of sweet. Diabetes is not a curable but it
is controllable through some tips. Only anti- diabetic drugs are not controlle the diabetes
with this drug Daily exercise, diet management & Yoga is play an important role to
controlle the diabetes.
The aged (old) people suffer more towards the diabetes disorder. There are lots
of factors responsible for diabetes.
101
Few doctors were reluctant to give proper information and few of them were
unreachable.
The survey is carried out only in Navi Mumbai Dist. And some part of Mumbai. So
the interpretation drawn from the data available may be insufficient to comment on
the launch of the product in other cities of the country.
102
Summary of Analysis
As we look on to the insulin, it show prolong action to treating diabetes. Insulin is
available in the form of humulinbut this insulin are expensive therefore its market is
just 30% among diabetes drug. in spit of being expensive yet it is demanded in the
market. It show that it is increasing at the rate of 27% in the market. If the
manufacture could make insulin little less than before then insulin could be used by
more and more diabetes patients.
The cheapest drug found in the market is Daonil by Aventis which is at Rs 18 for
10tablets and semi Dao nil for Rs. 9for 10tablets. This daonil tablets were extremely
used in last two decades as the other firm drug come in to the market. Which more
effective but just above the price. As per the information, drug manufactures are
increasing the price which can effect their share mostly. The ant diabetic are available
in the price range from Rs.28 to Rs.135 according to their R&d cost and strength
availability price must be frequently low then the ma rket price.
103
APPENDIX
ANNEXURE-I
LIST OF DOCTORS NAME
S.NO
Doctor Name
Qualification
Category
A L joshi
MD
Cons.Phys
A M Nike
MBBS
Cons.Phys
ABHISAR
KATIYAR
MS ORTHO
Ortho
ABJALPURKAR
MBBS
G.P.
AJAY MEHETA
MD
physician
AL PARMAL
MBBS
G.P.
ALKANANDA DAS
MBBS
physician
AMOD DIVEKAR
MS ORTHO
Ortho
ANIL DONGRE
MD.DPM
Psychiatrists
10
ANIL MEHETA
MBBS
G.P.
11
ANIL SHANKAR
MBBS
G.P.
12
ANIL TALATHI
MBBS
G.P.
13
ARVIND JOSHI
MD
physician
104
14
ARVIND KOTOC
MBBS
G.P.
15
ASHOK BHOIR
MBBS
G.P.
16
ASHOK JADHAV
MD
physician
17
ayati ganhi
md
Cons.Phys
18
B G MEHTA
MBBS
G.P.
19
B. KHEDEKAR
MBBS
G.P.
20
B.G.KAMBLE
MD
physician
21
B.J.SHINDE
MD
physician
22
C.D. KULKARNI
MBBS
G.P.
23
D.A. SHIRODKAR
MD
physician
24
D.V.DIVEKAR
MBBS
G.P.
25
deepak mane
md dpm
Psychiatrists
26
DEEPAK PUROHIT
MS ORTHO
Ortho
27
DEEPAK
WAJEKAR
MBBS
G.P.
28
DEPALI MANE
MBBS
G.P.
105
29
DEVIDAS
GHANATE
MD
physician
30
DILIP JAIN
MBBS
G.P.
31
FAIZAL
DESHMUKH
MD
physician
32
FARAH
NAZAEKAR
MBBS
G.P.
33
G.S.KADAM
MBBS
G.P.
34
G.S.PATIL
MBBS
G.P.
35
HARSHAL
WALINGKAR
MS ORTHO
Ortho
36
HEMANT DALVI
MD
physician
37
j n kolhe
Mbbs
G.P.
38
jagdish bedekar
mbbs,md
physician
39
K C METHA
MBBS
G.P.
40
kaustik seth
Mmbs
G.P.
41
KIRTI SAMUDRA
MD
physician
42
KUMAR SHINDE
MBBS
G.P.
43
L.D.PATIL
MBBS
G.P.
44
M.L. LAD
MD
physician
45
M.M. DOSHI
MBBS
G.P.
106
46
Madhav g bhaware
md
physician
47
MADHURI KALITA
MBBS
Cons.Phys
48
madhusudan joshi
md
G.P.
49
SHAILESH
PAREKH
MD
PHY.
50
GIRISH MOHAARI
MD
PHY.
107
ANNEXURE-II
LIST OF CHEMIST SHOP
S No.
Shree medicose
10
Vikas medicose
11
12
13
14
15
16
17
18
19
Medi sales
20
21
22
Roz medical
23
108
24
25
26
Ruby pharmacy
27
28
29
30
31
Mir pharma
32
33
34
35
36
37
Pooja pharma
38
39
40
109
ANNEXURE-III
Doctors Questionnaire
Name-
Qualification
Age-
Specialty-
Area-
110
Questionnaire:
1. How Many diabetes patient treat in one month ? ______________
2. What type of diabetes patients approach you?
NIDD
IDD
NO
NO
NO
9. Have you seen any side effects of the anti diabetic drug you prescribe?
YES
NO
If
yes,
____________________________________________________________
what
111
ANNEXURE-IV
QUESTIONNAIRES
Shop Name-
Area-
Nearby Doctor-
112
7.
8. Huminsuli-R is Sold due to
a) MR Influence
b) Low Price
c) Margin of profit
ANNEXURE-V
REFERENCES
BOOKS REVIEW:
a) Michael Wilson, Rod McNab, Brian Henderson
Bacterial Disease Mechanisms - An Introduction to Cellular Microbiology
Cambridge University Press April 2002
b) Edited by Charles J Dutton, Mark A Haxell, Hamish A. I. McArthur and Richard
G. Wax
ANTIDIABETIC - Discovery, Modes of Action, and Applications
Marcel Dekker December 2001
c) Edited by Wilson & Gisvold's
Wilson & Gisvold's Textbook of Organic Medicinal and Pharmaceutical Chemistry
11th Ed.
Oregon State University, Corvallis.
d) Edited by K Kumme rer
Pharmaceuticals in the Environment - Sources, Fate, Effects and Risks - 3rd
Edition
Springer 2008
e) Alan Nathan
Non-Prescription Medicines 2nd Edition
f) Stuart Hogg
Essential Microbiology
Wiley June 2005
g) Research Methodology
By Uma Shekharan
Websites
www.wikipedia.com
www.diabeticindia.com
www.diabeticinformationhub.com
www.cygnusindia.com
www.herbalgram.org
www.marketresearch.com
www.diabetescare.com www.thehindu.com
114