Once-weekly dulaglutide non-inferior to once-daily liraglutide in reduction of HbA1c
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 in the AWARD-6 study. The AWARD (Assessment of Weekly AdministRation of LY2189265 in Diabetes)-6 trial evaluated once-weekly dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist as a treatment for type 2 diabetes, in 599 patients on concomitant metformin.
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.
AWARD-6 is the sixth of a series of randomised AWARD trials in which once-weekly dulaglutide was evaluated against placebo and other active comparators. AWARD 1-5 had demonstrated superiority in reduction of HbA1c at the 1.5 mg dose.
Once-weekly dulaglutide has been submitted to the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory bodies. "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." Says Enrique Conterno, president of Lilly Diabetes in a press release.
Eli Lilly Press release Feb 25 2014