The Juvenile Diabetes Research Foundation (JDRF) and Amylin Pharmaceuticals will enter 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 I 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.
This collaboration, consisting of formulation and clinical work, will investigate whether a fixed ratio of pramlintide and insulin can effectively help treat type I diabetes. The formulation research will assess the feasibility of co-formulating pramlintide and insulin (both currently administered using separate injections) as a single injection.
An optimal ratio of pramlintide and insulin will be identified through modeling work. In a series of up to three clinical proof-of-concept studies, the program will also investigate the optimal pramlintide:insulin dose ratios, and determine whether delivering pramlintide and insulin in this fixed ratio, can improve glucose control and optimize treatment of type 1 diabetes compared with insulin alone.