Lilly's diabetes drug dulaglutide does well in two additional trials

US drug major Eli Lilly (NYSE: LLY) has released positive top-line results of two additional Phase III AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist being studied as a once-weekly treatment for type 2 diabetes.

Primary efficacy endpoints of non-inferiority to insulin glargine, as measured by the reduction of hemoglobin A1c (HbA1c) levels at the 1.5mg dose, were met in two studies (AWARD-2 and AWARD-4). Having met the primary endpoints, superiority for HbA1c lowering was examined. The dulaglutide 1.5mg dose demonstrated statistically superior reduction in HbA1c from baseline compared to insulin glargine at 52 weeks in patients with type 2 diabetes on metformin and glimepiride (AWARD-2). The dulaglutide 1.5 mg dose in combination with insulin lispro demonstrated statistically superior reduction in HbA1c from baseline compared to insulin glargine in combination with insulin lispro at 26 weeks (AWARD-4).

Across these two additional completed AWARD (Assessment of Weekly AdministRation of LY2189265 in Diabetes) studies, the most frequently reported adverse events were gastrointestinal-related. These adverse event findings are consistent with prior studies of dulaglutide.