Last updated on November 5, 2018

www.M3GlobalResearch.com

© 2018 M3 USA Corporation. All rights reserved.

WHAT IS DIABETES?

Diabetes mellitus is a metabolically complex, chronic, and progressive disease. The disease aff ects the body’s ability to produce or use the hormone insulin and is sometimes referred to as dysfunction of glucose homeostasis. When your body turns the food you eat into energy (also called sugar or glucose), insulin is released to help transport this energy into the cells. Patients with diabetes have high blood glucose levels due either to the inability to produce suffi cient quantities of insulin or low absorption of the available insulin into their cells (insulin insensitivity.)

Untreated diabetes carries the risk of severe complications from extended exposure to high glucose levels, especially in smaller blood vessels. Common comorbidities include heart disease, stroke, blindness, kidney failure, severe neuropathies, and risk of amputation in the lower limbs.

There are two primary types of diabetes, type 1 and type 2. The primary diff erence between type 1 and type 2 is that type 1 diabetes is an autoimmune condition where the body’s own immune system attacks the pancreas, resulting in the inability to make insulin. Patients with type 1 diabetes (T1DM) require insulin therapy on a frequent basis to maintain normal blood glucose levels. Patients with type 2 diabetes (T2DM) have lost over time the ability to either produce enough insulin or are unable to utilize the insulin that is produced in the body—with the same resulting high glucose levels. T2DM is considered a milder form of diabetes and is the most prevalent type of diabetes, aff ecting 90 percent or more of patients with the disease.

A third type of diabetes is far less common and occurs during pregnancy. The American Diabetes Association estimates gestational diabetes aff ects about 18 percent of all pregnancies. This form of diabetes usually resolves a� er the pregnancy, and sometimes uncovers T1DM or T2DM conditions.

Another emerging condition is pre-diabetes, which causes a person’s

M3 GLOBAL RESEARCH THERAPEUTIC REVIEW

DIABETES

QUICK FACTS

Diabetes is the direct

cause of death in approximately

1.6 millionpeople annually

The number of people with diabetes is expected to

rise to 522 million by 2030

75% of people with diabetes live in low- and middle-

income countries

Approximately

25% of the population

65+ yearshas diabetes

1-IN-2 people with diabetes

(212 million) remain undiagnosed

84 millionpeople in the US are estimated

to have pre-diabetes

14th November is World Diabetes Day in honor of the birthday of F.G. Banting who, along with C.H. Best, purifi ed insulin from a dog’s pancreas in 1922. World Diabetes Day is the world’s largest diabetes awareness campaign and it is supported by many organizations.

Last updated on November 5, 2018

www.M3GlobalResearch.com © 2018 M3 USA Corporation. All rights reserved.

blood sugar levels to be higher than normal but not high enough to be diagnosed with diabetes. Patients with prediabetes are considered to have a higher risk of developing diabetes in the future.

WHO SUFFERS FROM DIABETES?Patients with type 1 diabetes are o� en diagnosed as children. T2DM used to be called adult-onset diabetes, but that has been revised given the growing problem of obesity in children and teenagers. The incidence of diabetes advances with age, and estimates suggest approximately 25 percent of the population 65 years and older has diabetes.

The incidence and prevalence of diabetes has been growing steadily around the world. The World Health Organization (WHO) estimates the number of patients has increased from 108 million in 1980 to 422 million patients living with diabetes in 2014, or roughly 8.5 percent of people over the age of 18. It is the direct cause of death in approximately 1.6 million people each year. Another 2.2 million deaths per year are attributed to complications of high blood sugar leading to stroke, heart attacks, blindness, neuropathy, kidney disease, and even amputation of limbs due to blood vessel damage and foot ulcers.

Diabetes is one of four priority noncommunicable diseases (NCDs) targeted for action by world leaders. In light of the dramatically strong links between obesity and diabetes, the WHO, in 2017, started the Healthy Life Trajectories Initiative (HeLTI) to build on their “Ending Childhood Obesity” (ECHO) program.

In the US, the Centers for Disease Control and Prevention (CDC) estimates the number of patients

with diabetes at 30 million, 9.4 percent of the general population. Another 84 million people in the US are estimated to have pre-diabetes and are at risk for developing type 2 diabetes if there is no improvement in their health practices.

Diabetes is a major cause of healthcare spending in the US, totaling roughly $245 billion in 2015. This is more than twice the spending for patients without diabetes. Diabetes is estimated to be the seventh leading cause of death in the US, similar to the worldwide disease rank in cause of death.

HOW IS DIABETES TREATED?Diagnosis of diabetes is o� en made via measuring blood glucose levels and by monitoring HbA1c enzyme levels. A1c levels are a measure of the average blood glucose levels over the previous three months, and current monitoring standards call for measuring A1c levels several times a year to maintain those below seven. Many people use portable glucose monitoring kits to measure blood glucose via fi nger sticks.

There is no cure for diabetes. Patients with T1DM are taking various forms of insulin. Long-acting forms have a long half-life in the body and allow for dosing daily or a few times a week. Short-acting forms of insulin are utilized for more immediate control around mealtimes or a few times a day. Patients with more severe diabetes are o� en placed on an insulin pump to facilitate more frequent insulin delivery needs. Inhaled insulin introduced in recent years remains underutilized, despite many patients desire to avoid injections of insulin.

Patients with T2DM have several therapy options.

M3 GLOBAL RESEARCH THERAPEUTIC REVIEW

DIABETES

Last updated on November 5, 2018

www.M3GlobalResearch.com © 2018 M3 USA Corporation. All rights reserved.

Metformin is o� en a foundation therapy to limit glucose production in the liver, and other therapies build on that foundation with combination therapy. Common strategies include stimulating the pancreas to produce more insulin (DPP-IV, GLP-1 inhibitors) or decrease insulin insensitivity to let more insulin into target cells and utilize existing insulin levels. SGLT-2 inhibitors block glucose reabsorption in the kidneys to excrete it in the urine. Despite attempts to provide patients with strategies to control blood glucose levels, the US American Diabetes Association estimates that even with therapy, up to 49 percent of patients don’t achieve their glycemic control target A1c levels. And, just 14 percent of patients are successful at controlling all three: blood pressure, lipids, and A1c metrics.

Research into therapies and treatments for patients with diabetes is an extremely active area, and numerous classes of oral and injectable products attempt to provide glycemic control. The fi rst closed loop system to mimic pancreatic function by combining a continuous

blood glucose monitor paired with an insulin pump to maintain blood glucose levels at all times was approved in 2016. Stem cell therapy to create beta cells for transplantation into the pancreas to create or supplement insulin production is also being studied. Technology is being introduced to provide glucose levels through various means such as contact lenses and smart watches. Artifi cial intelligence is being investigated to provide tools for the prediction and prevention of TDM complications.

M3 GLOBAL RESEARCH THERAPEUTIC REVIEW

DIABETES

M3 KNOWS DIABETESM3 is active in recruiting for our clients’ studies in diabetes. In 2017, we recruited over 3,500 respondents for more than 40 studies with clients across multiple countries. Most were online quantitative surveys, 21 were qualitative only projects, and two included both study type activities. Endocrinology in general was the primary topic area in 2016 for over 140 studies among more than 7,000 respondents in 15 countries.

M3 also provides several syndicated services in this sector. Physician Map is a KOL mapping service off ered in your custom disease areas. Patients Map is a 5,000-respondent syndicated service that examines patient loads across 400 diseases.

For additional information on accessing our robust global panel of endocrinologists, patients, and caregivers, contact research@usa.m3.com.