Eli Lilly and Company (NYSE: LLY) today announced 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 1.5 mg dose, were met in two studies (AWARD-2 and AWARD-4). Having met the primary endpoints, superiority for HbA1c lowering was examined. The dulaglutide 1.5 mg 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 glimeperide (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.
In October 2012, Lilly announced positive top-line results of three other completed Phase III AWARD trials: AWARD-1, AWARD-3 and AWARD-5. Primary efficacy endpoints, as measured by reduction in HbA1c at the 1.5 mg dose, were met in all three. The five AWARD studies (1-5) will support registration filings of dulaglutide.
"Dulaglutide, if approved, further advances our efforts to offer a broad portfolio of therapies for people with diabetes, many of whom have unique needs," said Enrique Conterno , president of Lilly Diabetes. "The results of our Phase III dulaglutide trials are encouraging and we look forward to sharing more details on the AWARD studies at upcoming scientific meetings."
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 in 2013.
Global gap in diabetes prevalence and treatment has widened since 1990