Eli Lilly and Company has released detailed results from dulaglutide's sixth AWARD trial, showing that once-weekly dulaglutide 1.5 mg was non-inferior to once-daily liraglutide 1.8 mg. The non-inferiority study demonstrated similar reductions in average blood sugar levels (HbA1c) across both arms.1 The head-to-head study compared the safety and efficacy of dulaglutide and liraglutide, two glucagon-like peptide-1 (GLP-1) receptor agonists. These results will be presented at the 74th American Diabetes Association Scientific Sessions in San Francisco.
"We're delighted by the results of the AWARD-6 trial - the first Phase III study in which a GLP-1 receptor agonist demonstrated non-inferiority to liraglutide," said Sherry Martin, M.D., senior medical director, Lilly Diabetes. "If approved, dulaglutide would be the only GLP-1 agonist that is both once-weekly and ready-to-use. We believe it could provide patients and physicians an important new treatment option for type 2 diabetes."
At the primary endpoint of 26 weeks, once-weekly dulaglutide 1.5 mg and once-daily liraglutide 1.8 mg significantly reduced HbA1c levels from baseline (-1.42 percent and -1.36 percent, respectively), with dulaglutide demonstrating non-inferiority compared to liraglutide. A similar majority of patients in both treatment groups (68 percent) reached the American Diabetes Association's recommended HbA1c target of less than 7 percent.1 Patients treated with once-weekly dulaglutide and once-daily liraglutide showed significant weight reductions from baseline (-2.9 kg, -3.6 kg, respectively). This weight reduction was statistically greater in the liraglutide treatment arm.1
Average hypoglycemia rates were similar between patients treated with once-weekly dulaglutide (0.34 events/patient/year) and once-daily liraglutide (0.52 events/patient/year), with no reported severe hypoglycemia events.
Adverse events were also very similar between the two treatments, with gastrointestinal-related events, including nausea, diarrhea and vomiting, the most frequently reported. Nausea, which was mostly mild to moderate and transient, was the most commonly reported event for both once-weekly dulaglutide and once-daily liraglutide. These findings are consistent with prior studies of once-weekly dulaglutide.1
"Diabetes is a progressive disease that affects every patient differently," said Kathleen Dungan, MD, endocrinologist, associate professor, The Ohio State University Wexner Medical Center. "It's important for physicians to have choices that can help their patients find a better way to manage their diabetes. These results are encouraging, as they show that dulaglutide could be a promising new treatment option for patients with type 2 diabetes."
Once-weekly dulaglutide, an investigational, long-acting GLP-1 receptor agonist being studied as a treatment for type 2 diabetes, has been submitted to the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory bodies. Five AWARD registration trials (1-5) were submitted as part of the regulatory package. If approved, dulaglutide will be marketed under the brand name Trulicity™.
About the AWARD-6 Study
AWARD (Assessment of Weekly AdministRation of LY2189265 in Diabetes)-6 trial was a randomized, open-label, parallel-arm study comparing the effects of once-weekly dulaglutide and once-daily liraglutide on glycemic control in patients with type 2 diabetes on concomitant metformin. The primary objective of the study, conducted in 599 patients, was to evaluate whether dulaglutide 1.5 mg, dosed once-weekly, was non-inferior to liraglutide 1.8 mg, dosed once-daily, in reducing HbA1c from baseline at 26 weeks.