US pharma major Eli Lilly (NYSE: LLY) reported positive top-line results of three completed Phase III AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) analog being studied as a once-weekly treatment for type 2 diabetes.
Primary efficacy endpoints, as measured by reduction in hemoglobin A1c (HbA1c) at the 1.5 mg dose, were met in three studies (AWARD-1, AWARD-3 and AWARD-5). Having met the primary endpoints, superiority for HbA1c lowering was examined, and both doses of dulaglutide (0.75mg and 1.5mg) demonstrated statistically superior reduction in HbA1c from baseline compared to: Amylin’s GLP-1 agonists, Byetta (exenatide) twice-daily injection at 26 weeks (AWARD-1); metformin at 26 weeks (AWARD-3); and Merck & Co’s Januvia (sitagliptin) at 52 weeks (AWARD-5).
Across the three completed AWARD studies, the most frequently reported adverse events were gastrointestinal-related. These adverse event findings are consistent with prior studies of dulaglutide.
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