Two Additional Positive Phase 3 Results for Dulaglutide

Eli Lilly and Company announced positive top-line results of two additional Phase 3 AWARD (Assessment of Weekly AdministRation of LY2189265 in Diabetes) 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-2 was a randomized, 78-week, open-label comparison of the effects of dulaglutide and insulin glargine (Lantus; Sanofi Aventis) on glycemic control in patients with type 2 diabetes on metformin and glimepiride (Amaryl; Sanofi Aventis).  The primary objective of the study, conducted in 807 patients, was to evaluate whether dulaglutide 1.5mg, dosed once-weekly, is non-inferior to insulin glargine in reducing hemoglobin A1c (HbA1c) from baseline at 52 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 dulaglutide and insulin glargine, both in combination with insulin lispro (Eli Lily and Company), in patients with type 2 diabetes.  The primary objective of the study, conducted in 884 patients, was to evaluate whether dulaglutide 1.5mg, dosed once-weekly, in combination with insulin lispro, is 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.

The primary efficacy endpoints of non-inferiority to insulin glargine, as measured by the reduction of HbA1c levels at the 1.5mg dose, were met in two studies (AWARD-2 and AWARD-4). Superiority for HbA1c lowering was examined since the primary endpoints were met. Dulaglutide 1.5mg demonstrated statistically superior reduction in HbA1c from baseline compared to insulin glargine at 52 weeks in patients with type 2 diabetes on metformin and glimeperide (AWARD-2).  In AWARD-4, dulaglutide 1.5mg  in combination with insulin lispro demonstrated statistically superior reduction in HbA1c from baseline compared to insulin glargine in combination with insulin lispro at 26 weeks.  

Previously Lilly announced positive top-line results of three other completed Phase 3 AWARD trials: AWARD-1, AWARD-3 and AWARD-5. Primary efficacy endpoints, as measured by reduction in HbA1c at the 1.5mg dose, were met in all three.

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