Once-Weekly BYDUREON™ Provided Greater Glucose Control, Weight Loss And Lower Risk Of Hypoglycemia Compared To Once- Or Twice-Daily Levemir® In Type 2 Diabetes

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced clinical study results which showed that a significantly greater proportion of patients treated with BYDUREON™ (exenatide extended-release for injectable suspension), the first and only once-weekly treatment for type 2 diabetes, achieved target glucose levels and weight loss compared to those treated with Levemir ^® (insulin detemir). The study is being presented at the 72nd Scientific Sessions of the American Diabetes Association in Philadelphia.

In the study, 44.1 percent of patients receiving BYDUREON, compared with 11.4 percent of those treated with insulin detemir, met the primary composite endpoint of A1C less than or equal to 7 percent and weight loss greater than or equal to 2.2 pounds (P less than 0.0001) at 26 weeks. Treatment with BYDUREON also resulted in greater improvement in A1C (-1.3 percentage points) than insulin detemir (-0.88 percentage points). A1C is a measure of average blood sugar over three months. Patients receiving BYDUREON lost an average of 5.9 pounds, while those receiving insulin detemir gained an average of 1.8 pounds, resulting in a treatment difference of 7.7 pounds.

“In this study, treatment with BYDUREON resulted in a significantly greater proportion of patients achieving target glucose levels compared to insulin detemir and was associated with weight loss and a lower risk of hypoglycemia,” said Melanie J. Davies, M.D., FRCP, professor of diabetes medicine at the University of Leicester, United Kingdom and honorary consultant at University Hospitals of Leicester. “In everyday clinical practice, glycemic control, weight management and hypoglycemia risk are all critical factors in managing type 2 diabetes, and these data suggest that BYDUREON may be a good alternative to insulin detemir in type 2 diabetes patients who are not achieving adequate glycemic control on metformin with or without a sulfonylurea.”

There were no events of major hypoglycemia in either group. Gastrointestinal-related and injection-site-related adverse events occurred more frequently with BYDUREON than with insulin detemir.

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