Lilly announced positive top-line results of three completed Phase 3 AWARD trials for dulaglutide, 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 (Byetta; Amylin and Lilly) on glycemic control in patients with type 2 diabetes on metformin (Glucophage; Bristol-Myers Squibb) and pioglitazone (Actos; Takeda).  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 1.5mg, 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.

AWARD-5 was a randomized, 104 week, double-blind, placebo-controlled comparison of the effects of dulaglutide and sitagliptin (Januvia; Merck) 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, 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.


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Primary efficacy endpoints were met in the three studies.  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).

Dulaglutide is an investigational, long-acting glucagon-like peptide 1 (GLP-1) analog.

For more information call (800) 545-5979 or visit www.lilly.com.