Dulaglutide Superior to Comparators for Glycemic Control

Eli Lilly and Company announced safety and efficacy results from three Phase 3 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.

AWARD-1 was a randomized, 52-week, placebo-controlled comparison of the effects of 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 1.5mg, dosed once-weekly, is superior to placebo in reducing HbA1c from baseline at 26 weeks.

AWARD-3 was a randomized, 52-week, double-blind comparison of the effects of 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 1.5mg, dosed once-weekly, is 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-5 was a randomized, 104 week, double-blind, placebo-controlled comparison of the effects of 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 1.5mg, dosed once-weekly, is 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.

In the trials, dulaglutide 1.5mg was superior to placebo and to exenatide (AWARD-1), metformin (AWARD-3) and sitagliptin (AWARD-5) in reducing HbA1c levels. In addition, a greater percentage of patients treated with dulaglutide 1.5mg achieved an HbA1c goal of less than 7% vs. all active comparators. In all three studies, patients taking dulaglutide 1.5mg showed sustained weight loss for the duration of the trials. Patients taking dulaglutide 1.5mg showed significant weight loss compared to patients taking sitagliptin (AWARD-5), and showed similar weight loss to patients taking comparators in AWARD-1 and AWARD-3.

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