Dulaglutide (Eli Lilly) success in AWARD Phase III trials for Type 2 Diabetes

Eli Lilly and Company has announced 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: exenatide twice-daily injection at 26 weeks (AWARD-1); metformin at 26 weeks (AWARD-3); and 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.Lilly plans to present detailed data from the AWARD studies at scientific meetings in 2013 and 2014. The company expects to submit dulaglutide to regulatory authorities during 2013 with the timing of regulatory submission in the United States dependent upon satisfactory completion of FDA requirements for assessment of cardiovascular risk.