Global pharmaceutical company Eli Lilly released positive top-line results of three completed phase III AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) analog being studied as a once-weekly treatment for type 2 diabetes.

Primary efficacy endpoints, as measured by reduction in hemoglobin A1c (HbA1c) at the 1.5mg dose, were met in three studies (AWARD-1, AWARD-3 and AWARD-5).  Having met the primary endpoints, superiority for HbA1c lowering was examined, and both doses of dulaglutide (0.75mg and 1.5mg) demonstrated statistically superior reduction in HbA1c from baseline compared to: exenatide twice-daily injection at 26 weeks (AWARD-1); metformin at 26 weeks (AWARD-3); and sitagliptin at 52 weeks (AWARD-5).

Across the three completed AWARD studies, the most frequently reported adverse events were gastrointestinal-related. These adverse event findings are consistent with prior studies of dulaglutide.

"We're very encouraged by the results to date from our phase III dulaglutide trials and are pleased to be one step closer to offering a new GLP-1 treatment option for type 2 diabetes," said Enrique Conterno, president of Lilly Diabetes.

The AWARD-1 study 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, was 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 1.5 mg, dosed once-weekly, was non-inferior to metformin in reducing HbA1c from baseline at 26 weeks.  Superiority testing was performed as the statistical criterion for non-inferiority was satisfied.

The AWARD-5 trial 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 1.5 mg, dosed once-weekly, was non-inferior to sitagliptin in reducing HbA1c from baseline at 52 weeks.  Superiority testing was performed as the statistical criterion for non-inferiority was satisfied.

There are a number of additional AWARD trials ongoing. Two of these studies for submission, AWARD-2 and AWARD-4, will conclude in the next few months. Lilly expects to submit dulaglutide to regulatory authorities during 2013 with the timing of regulatory submission in the U.S. dependent upon satisfactory completion of FDA requirements for assessment of cardiovascular risk.