Eli Lilly, Amylin announce clinical trial results of exenatide

INDIANAPOLIS A drug under review by the Food and Drug Administration as a treatment for diabetes provided better glucose control than the competition, the drug’s developers said Monday.

Eli Lilly & Co., Amylin Pharmaceuticals and Alkermes announced results of a phase 3 clinical trial comparing a once-weekly formulation of exenatide, the active ingredient in the drug Byetta, to Sanofi-Aventis’ Lantus (insulin glargine [rDNA origin]). The trial found that patients taking exenatide experienced reductions in average blood sugar levels of 1.5%, compared with 1.3% among those taking Lantus. Exenatide also resulted in an average weight loss of 5.8 lbs. after 26 weeks, compared with 3.1 lbs. among Lantus patients.

“Exenatide once-weekly outperformed Lantus in this superiority study by meeting its primary endpoint,” Amylin Pharmaceuticals SVP research and development Orville Kolterman said in a statement.

The study enrolled 467 patients with Type 2 diabetes, with more than 90% of patients completing it.