November-Diabetes

November is American Diabetes Month

Today in the United States, 25.8 million children and adults, or nearly 8.3% of the population, have diabetes, a disease in which the person’s body does not produce or correctly use insulin.^[i] Insulin is a hormone that helps change glucose (sugar) and other foods into energy. Each day, approximately 4,110 people are diagnosed with diabetes. New cases of diabetes have risen more than 90 percent among adults over the last 10 years, and since 1987 the number of deaths from the disease has risen by 45 percent, according to the U.S. Centers for Disease Control and Prevention and the American Diabetes Association.

Recognizing the impact that diabetes has on such a large portion of the population, Innovation.org highlights important and innovative research into new treatments for diabetes. This new research will not only reduce the burden on those living with diabetes, but it can also reduce healthcare costs. Learn more below about diabetes, new medicines and research intiatives to improve treatment, and review charts and graphs related to diabetes research trends.

New Medicines in Development

A record 235 new medicines to treat diabetes, one of the fastest-growing diseases in America, are being developed by America’s biopharmaceutical companies acording to a recent report. The new medicines currently in the pipeline, some in early development stages and some awaiting FDA approval, include numerous drugs to treat eye diseases associated with diabetes. New medicines to treat foot ulcers could reduce the need for amputations. Researchers are pushing into new territories that include gene therapy and are working on such treatments as a once-weekly medication similar to a natural hormone critical to blood sugar regulation. Read more

Selected Medicines in Development for Diabetes

Improving Glycemic Control – A once-weekly medicine in development has shown in clinical trials to significantly improve control of blood glucose levels and weight loss. The medicine’s structure is similar to that of a natural human hormone (GLP-1) that plays a significant role in blood sugar regulation. It stimulates insulin production and reduces the secretion of glucagons (hormones involved in carbohydrate metabolism). By increasing levels of GLP-1 the medicine could improve the imbalance between insulin and glucose that causes type 2 diabetes.

Reducing Insulin Resistance – A medicine in development addresses insulin resistance, an underlying cause of type 2 diabetes, by modulating genes responsible for insulin sensitization. In clinical trials, the potential medicine has been shown to lower blood glucose, triglyceride and uric acid levels without weight gain or edema by selectively modifying gene expression needed for insulin sensitization without activating the genes responsible for weight gain and edema.

Lowering Cardiovascular Risk – A medicine in development for the treatment of type 2 diabetes is comprised of two proteins that regulate the expression of genes that are responsible for lipid homeostasis (the process of maintaining internal balance of lipids within cells) and insulin resistance (when the body produces insulin but does not use it properly). Due to its dual action, it is expected to be effective as a single drug for addressing both high blood sugar and cholesterol problems, while also lowering the cardiovascular risk in patients with diabetes.

Once-Daily Oral Treatment – A potential medicine in development is an oral agent for the once-daily treatment of type 2 diabetes. The medicine was designed to selectively inhibit the protein associated with glucose metabolism but not other closely related proteins that are associated with other biologic activity. The medicine blocks the degradation of incretin hormones that are released in the digestive tact in response to food, and mediate glucose-dependent insulin secretion. In type 2 diabetes, the incretin levels are decreased, contributing to insulin deficiency and high blood sugar.

Painful Nerve Damage – Nerve damage is a common symptom of diabetes, about half of all people with diabetes have some form of nerve damage, according to the American Diabetes Association. Over time, blood glucose can injure the walls of tiny blood vessels that nourish nerves causing pain, especially in the legs. A medicine in development is designed to improve the symptoms of diabetic neuropathy by inhibiting the activity of an enzyme that causes the accumulation of intracellular sorbitol that causes diabetic neuropathy.

Recent FDA Approvals for Diabetes Treatment

Victoza® (liraglutide) – approved for the treatment of type 2 diabetes (1/25/2010)
Onglyza™ (saxagliptin) – approved for the treatment of type 2 diabetes (7/31/2009)

To view a list of new treatments for a variety of indications, visit the Recent FDA Approvals Page.

Research trends for specific patient populations

Children
Diabetes affects about 215,000 Americans under the age of 20, and about 2 million adolescents between the ages of 12 and 19 have pre-diabetes, according to the American Diabetes Association. One medicine, the first DPP-4 (dipeptidyl peptidase-4) inhibitor already approved for use in adults, is being tested in children with type 2 diabetes. Read more

Women
Diabetes affects about 12.6 million American women over the age of 20, according to the American Diabetes Association. Read more

Older Americans
Among Americans age 65 and older, 10.9 million have diabetes, according to the American Diabetes Association. Uncontrolled diabetes can lead to kidney failure, blindness, amputations and premature death. A new, first-in-class medicine in development addresses insulin resistance, the underlying cause of type 2 diabetes. Read more

Controlling Healthcare Costs

In 2007, the total cost of diabetes in the United States totaled $174 billion, according to the American Diabetes Association. New diabetes medicines are helping patients avoid serious complications and death, and they can reduce overall healthcare spending. In one study, increased patient adherence to diabetes medicines saved $7 for every additional dollar spent on medicines. Read more

The Biomarkers Consortium

In June 2009, the Biomarkers Consortium, a public-private partnership launched by the Foundation for the National Institutes of Health (FNIH), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA), announced the results of a study that demonstrated that the use of adiponectin, a hormone derived from fat cells, was confirmed as a robust biomarker predictive of glycemic efficacy in type 2 diabetes and healthy subjects. Currently, an existing biomarker, hemoglobin A1C (HbA1C), is the standard way of assessing a patient’s glycemic response to diabetes drugs, but in order to determine whether or not a treatment is effective for a patient with type 2 diabetes, it takes as much as three months to detect changes in HbA1C in response to changes in fasting glucose levels. The results of the Biomarkers Consortium’s study suggest that adiponectin can predict glycemic response in as little as six weeks and across the spectrum of glucose tolerance.

Click here to view more information about The Biomarkers Consortium.

Charts

Review the charts below for recent analyses specific to diabetes.

Click here to view all of Innovation.org’s charts.

^[i]American Diabetes Association. "Diabetes Statistics" http://www.diabetes.org/diabetes-basics/diabetes-statistics/?utm_source=WWW&utm_medium=DropDownDB&utm_

=Statistics&utm_campaign=CON (Accessed 1 November 2011).