Amylin, JDRF collaborate to investigate combination therapy for type 1 diabetes treatment

The Juvenile Diabetes Research Foundation (JDRF) and Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) announced today that they have entered into a research collaboration agreement to provide financial support for a series of clinical studies to investigate the feasibility of mixing pramlintide, an analog of the human hormone amylin, with insulin to treat type 1 diabetes. Pramlintide, marketed by Amylin as SYMLIN® (pramlintide acetate) injection, is approved for use as an adjunct treatment in patients with diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. SYMLIN and insulin are currently not approved to be mixed and must be administered as separate injections.  

"Type 1 diabetes is a chronic disease that requires blood sugar testing and insulin administration multiple times a day in order to keep blood glucose levels in check. The study of this combination therapy is exciting because, if successful, it could potentially help patients achieve tighter glucose control without increasing treatment complexity," said Aaron Kowalski, Ph.D., Assistant Vice President of Treatment Therapies for JDRF. "Successfully co-formulating pramlintide and insulin could potentially help people living with type 1 diabetes to better, and more conveniently, control their disease."

In a healthy pancreas, both insulin and amylin are produced and released by the same cells. The two hormones work together to help stabilize blood glucose levels. Insulin helps the body regulate production and storage of glucose, while amylin helps control the rate at which glucose enters the blood after meals.

"People with type 1 diabetes produce neither insulin nor amylin, and with insulin replacement alone, even with intensive basal/bolus therapy, managing blood sugar becomes a daily balancing act," said Matthew Riddle, M.D., Professor of Medicine, Division of Endocrinology, Diabetes, & Clinical Nutrition, Oregon Health & Science University. "Pramlintide may provide additional benefit for these patients by stabilizing their blood sugar levels, so they spend more time in the normal glucose range."

Currently, patients who use pramlintide must separately administer their daily insulin therapy, either through injections or an insulin pump. A co-formulated therapy that harnesses the benefit of both hormones might better mimic the natural physiology of the pancreas and simplify dosing decisions.

"Ultimately, it might reduce the complexity of daily treatment for patients who are working hard to manage this disease, and improve their ability to achieve treatment goals," continued Dr. Riddle.