JDRF, Amylin support clinical proof-of-concept study

NEW YORK and SAN DIEGO — A leading charitable funder of and advocate for Type 1 diabetes research and a drug maker have entered into a research collaboration agreement to provide financial support for a clinical proof-of-concept study to investigate the effects of an analog of the human hormone leptin in patients with Type 1 diabetes.

The Juvenile Diabetes Research Foundation and Amylin Pharmaceuticals said it would support researchers at the University of Texas Southwestern Medical Center, led by professor of internal medicine Roger Unger, who will conduct a study to determine if a treatment with metreleptin can help improve blood sugar control and decrease the daily doses of insulin required in patients with Type 1 diabetes.

The study will enroll 12 to 15 patients with Type 1 diabetes. Patients will add metreleptin twice a day to their usual insulin therapy over a five-month period. The insulin dosage will gradually be reduced to further characterize the effect of metreleptin on overall blood glucose.

Prior studies at UT Southwestern conducted in animal models with Type 1 diabetes showed an improvement in blood glucose, blood fats and cholesterol following administration of the hormone, JDRF and Amylin said.

"Better blood glucose control means healthier living for people with Type 1 diabetes," said Aaron Kowalski, assistant VP treatment therapies at JDRF. "If effective in humans, metreleptin, when used with insulin, could change the way people manage their disease. Less insulin usage and fewer low blood sugar episodes would represent a significant improvement in quality of life for certain people living with Type 1 diabetes today."