Eli Lilly and Company, a global healthcare leader, has reported 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 the US Food and Drug Administration (FDA), the European Medicines Agency (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.
AWARD-1 was a randomized, 52-week, placebo-controlled comparison of the effects of once-weekly dulaglutide and exenatide on glycemic control in patients with type 2 diabetes on metformin and pioglitazone. The primary objective of the study, conducted in 978 patients, was to evaluate whether dulaglutide 1.5 mg, dosed once-weekly, was superior to placebo in reducing HbA1c from baseline at 26 weeks.
AWARD-2 was a randomized, 78-week, open-label comparison of the effects of once-weekly dulaglutide and insulin glargine on glycemic control in patients with type 2 diabetes on metformin and glimepiride. The primary objective of the study, conducted in 807 patients, was to evaluate whether dulaglutide 1.5 mg, dosed once-weekly, was non-inferior to insulin glargine in reducing HbA1c from baseline at 52 weeks. Superiority testing was performed since the statistical criterion for non-inferiority was satisfied.
AWARD-3 was a randomized, 52-week, double-blind comparison of the effects of once-weekly dulaglutide and metformin on glycemic control in patients with early type 2 diabetes. The primary objective of the study, conducted in 807 patients, was to evaluate whether dulaglutide 1.5 mg, dosed once-weekly, was non-inferior to metformin in reducing HbA1c from baseline at 26 weeks. Superiority testing was performed since the statistical criterion for non-inferiority was satisfied.
AWARD-4 was a randomized, 52-week, open-label comparison of the effects of once-weekly dulaglutide and insulin glargine, both in combination with insulin lispro, in patients with type 2 diabetes. The primary objective of the study, conducted in 884 patients, was to evaluate whether dulaglutide 1.5 mg, dosed once-weekly, in combination with insulin lispro, was non-inferior to insulin glargine in combination with insulin lispro, in reducing HbA1c from baseline at 26 weeks. Superiority testing was performed since the statistical criterion for non-inferiority was satisfied.
AWARD-5 was a randomized, 104-week, double-blind, placebo-controlled comparison of the effects of once-weekly dulaglutide and sitagliptin on glycemic control in patients with type 2 diabetes on metformin. The primary objective of the study, conducted in 1,098 patients, was to evaluate whether dulaglutide 1.5 mg, dosed once-weekly, was non-inferior to sitagliptin in reducing HbA1c from baseline at 52 weeks. Superiority testing was performed since the statistical criterion for non-inferiority was satisfied.
AWARD-6 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.
Lilly has been a global leader in diabetes care and is building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them.