Positive results from exenatide phase 2 study in patients with type 2 diabetes

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes.

The 121-patient, phase 2 study assessed the efficacy, safety and tolerability of three different doses of exenatide once monthly. It also assessed exenatide once weekly (exenatide extended-release for injectable suspension, proposed brand name BYDUREON™), another investigational type 2 diabetes therapy. After 20 weeks of treatment (five injections), patients randomized to the exenatide once monthly treatment arms experienced average reductions in A1C ranging between 1.3 and 1.5 percentage points from baseline. In the once-weekly BYDUREON treatment arm, the reduction was 1.5 percentage points. A1C is a measure of average blood sugar over three months.

"As innovators in the treatment of type 2 diabetes we brought the first GLP-1 product, BYETTA, to patients. We are now developing once-weekly and once-monthly formulations of exenatide to expand patient choices for improving glycemic control," said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. "Based on the encouraging results of this study, we plan to proceed with regulatory interactions to outline the next steps for this important program."

More than 90 percent of patients overall completed the study. The most common adverse events among the exenatide once monthly treatment groups were headache and nausea. Headache and diarrhea were most common among the once-weekly BYDUREON group. No major or minor hypoglycemia was reported in the study.

Exenatide once monthly is a new, extended-release formulation of exenatide, the active ingredient in BYETTA^® (exenatide) injection, which is given twice daily. Exenatide once monthly is based on the same Medisorb^® microsphere technology used in BYDUREON.

Study Design

This phase 2, randomized, open-label study included 121 adults with type 2 diabetes who were not achieving adequate glucose control using diet and exercise alone or with a stable regimen of metformin, Actos^® (pioglitazone), or both. Subjects were randomized to receive either 2 mg weekly subcutaneous injections of BYDUREON or subcutaneous injections of exenatide once monthly at a low, medium or high dose, each administered once every four weeks, for a total of 20 weeks.