UT Southwestern will conduct the study, which is expected to enlist 12 to 15 patients.
The Juvenile Diabetes Research Foundation (JDRF) and Amylin Pharmaceuticals will provide financial support for a clinical proof-of-concept investigatation of metreleptin effects in patients with type 1 diabetes. The University of Texas (UT) Southwestern Medical Center will conduct the study of metreleptin, an analog of the human hormone leptin.
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 an improvement in blood glucose, blood fats, and cholesterol following administration of metreleptin.
The clinical trial is expected to 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, and the insulin dosage will gradually be reduced.
The trial will investigate whether treatment with metreleptin can help improve blood sugar control and decrease the daily doses of insulin required in patients with type 1 diabetes. It will also evaluate whether the treatment can improve variability in blood sugar levels, including the propensity for hypoglycemia.
The research collaboration agreement between JDRF and Amylin is part of JDRF’s Industry Discovery and Development Partnership (IDDP) program. JDRF partners with pharmaceutical, biotechnology, and medical device companies focused on the discovery, development, and delivery of therapeutics and devices for type 1 diabetes and its complications. Since the IDDP program was established in 2004, JDRF has reportedly funded 35 partnerships with 29 companies and committed approximately $71 million to accelerate research.
By aligning with Amylin, JDRF gains the backing of a company that has developed and gained approval for two first-in-class medicines for diabetes, Symlin® (pramlintide acetate) and Byetta® (exenatide).