Friday, March 4, 2011

Weekly Exenatide Misses Endpoint in Key Trial

By John Gever, Senior Editor, MedPage Today

An investigational once-weekly formulation of the injectable diabetes drug exenatide (Bydureon) failed to show noninferiority to daily liraglutide (Victoza), the trial's sponsors said.

In the open-label trial called DURATION-6, patients taking 2 mg of exenatide weekly showed a 1.3-point reduction in glycated hemoglobin (HbA1c) levels after 26 weeks, compared with a 1.5-point decrease in patients receiving liraglutide at 1.8 mg daily, according to a joint statement from Eli Lilly, Alkermes, and Amylin Pharmaceuticals, which are co-developing the once-weekly drug.

"Bydureon did not meet the prespecified primary endpoint of noninferiority to Victoza," the statement said.

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