Approximately 80 percent of patients completed the study. Consistent with previous DURATION trials, the most frequently reported adverse event in both groups was nausea, reported less frequently by exenatide once weekly users (14 percent) than by BYETTA users (35 percent). There were no major hypoglycemic events. Cases of minor hypoglycemia in both groups were limited to patients using background sulfonylurea therapy.

The 24-week, open-label superiority study included approximately 250 participants with type 2 diabetes who were not achieving adequate glucose control using background therapies that included diet and exercise, metformin, sulfonylurea, thiazolidinediones or a combination of the agents. Patients were randomized to receive either exenatide once weekly or BYETTA. Patients in the exenatide once weekly treatment arm received 2 milligrams once a week, while patients in the BYETTA arm received 5 micrograms twice a day for the first four weeks and 10 micrograms twice a day for the remaining 20 weeks. The primary endpoint was reduction in A1C; secondary endpoints included change in body weight and fasting plasma glucose, safety and tolerability.

Amylin, Lilly and Alkermes submitted a new drug application (NDA) for exenatide once weekly to the U.S. Food and Drug Administration (FDA) in May 2009; the NDA was accepted for review in July 2009. Lilly will be responsible for marketing exenatide once weekly outside the U.S. and expects to submit a marketing application to the European Medicines Agency by the end of the second quarter in 2010.

SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company