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Lilly Announces Positive Results Of Phase III Trials Of Dulaglutide In Type 2 Diabetes

About the AWARD ( Assessment of Weekly Administ Ration of LY2189265 in Diabetes) studies planned to support registration filings.

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-2 was a randomized, 78-week, open-label comparison of the effects of 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, is 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 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, 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-4 was a randomized, 52-week, open-label comparison of the effects of 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, 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.

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 1.5 mg, 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.

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