Foundation, Company Partner on Diabetes Clinical Study

(National Institutes of Health)

The Juvenile Diabetes Research Foundation (JDRF) in New York, N.Y. and Amylin Pharmaceuticals Inc. in San Diego, California said today they entered into an agreement to provide financial support for a clinical proof-of-concept study to investigate the effects of Amylin’s metreleptin, an analog of the human hormone leptin, in patients with type 1 diabetes. Researchers at The University of Texas (UT) Southwestern Medical Center in Dallas will conduct the study.

Leptin is a hormone secreted by fat cells that plays a fundamental role in the regulation of glucose metabolism. Prior studies at UT Southwestern conducted in animal models with type 1 diabetes showed improvements in blood glucose, blood fats, and cholesterol following administration of the hormone.

The clinical study will help to determine if similar improvements in glucose, and reduction of the amount of insulin required, can be achieved in people with type 1 diabetes. This is the first clinical study evaluating metreleptin treatment in patients with type 1 diabetes. The study will also evaluate whether treatment with metreleptin can improve variability in blood sugar levels, including the propensity for hypoglycemia (low blood sugar levels), which affects many people with type 1 diabetes.

The research collaboration agreement between JDRF and Amylin is part of JDRF’s Industry Discovery and Development Partnership program through which JDRF partners with pharmaceutical, biotechnology, and medical device companies.

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