Lilly's Once-Weekly Dulaglutide Shows Non-Inferiority to Liraglutide in Head-to-Head Phase III Trial for Type 2 Diabetes

Eli Lilly and Company has announced positive top-line results of the sixth AWARD (Assessment of Weekly AdministRation of LY2189265 in Diabetes) trial for once-weekly dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist being studied as a treatment for type 2 diabetes.

In the AWARD-6 study, once-weekly dulaglutide 1.5 mg achieved the primary endpoint of non-inferiority to once-daily liraglutide 1.8 mg, as measured by the reduction of hemoglobin A1c (HbA1c) from baseline at 26 weeks.

"Dulaglutide is the only GLP-1 agonist to show non-inferiority against liraglutide's highest-approved dose in a Phase III trial," said Enrique Conterno, president of Lilly Diabetes. "The AWARD-6 data, along with the previous five AWARD studies, give us confidence that dulaglutide can be an important treatment option for people with type 2 diabetes. If approved, dulaglutide would be the only GLP-1 agonist that is both once-weekly and ready-to-use."

Adverse events were similar for patients in both treatment groups. The most frequently reported events were gastrointestinal-related. These findings are consistent with prior studies of once-weekly dulaglutide.

Once-weekly dulaglutide has been submitted to FDA, EMA and other regulatory bodies. All previous five AWARD trials (1–5) included demonstrated superiority in reduction of HbA1c at the 1.5 mg dose against placebo and active comparators.

Lilly plans to present detailed data from the AWARD-6 (dulaglutide vs. liraglutide), AWARD-2 (dulaglutide vs. insulin glargine), and AWARD-4 (dulaglutide vs. insulin glargine; both in combination with insulin lispro) studies at scientific meetings later this year.