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Positive Phase III Results for Dulaglutide in Type 2 Diabetes

Non-inferiority to insulin glargine demonstrated in two studies (Apr. 16)

Positive results have been reported from two phase III trials of dulaglutide (Eli Lilly), an investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist that is being studied as a once-weekly treatment for type 2 diabetes.

Primary efficacy endpoints of non-inferiority to insulin glargine, as measured by the reduction of hemoglobin A1c (HbA1c) levels at the 1.5 mg dose, were met in the AWARD-2 (Assessment of Weekly AdministRation of LY2189265 in Diabetes 2) trial and in the AWARD-4 trial. Superiority for HbA1c lowering was also examined. The 1.5 mg dose of dulaglutide demonstrated a statistically superior reduction in HbA1c from baseline compared with insulin glargine at 52 weeks in patients with type 2 diabetes receiving metformin and glimepiride (AWARD-2 trial). In addition, the 1.5 mg dose of dulaglutide in combination with insulin lispro demonstrated a statistically superior reduction in HbA1c from baseline compared with insulin glargine in combination with insulin lispro at 26 weeks (AWARD-4 trial).

AWARD-2 was a randomized, 78-week, open-label comparison of the effects of dulaglutide and insulin glargine on glycemic control in 807 patients with type 2 diabetes receiving metformin and glimepiride. The study’s primary objective 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.

AWARD-4 was a randomized, 52-week, open-label comparison of the effects of dulaglutide and insulin glargine, both administered in combination with insulin lispro, in 884 patients with type 2 diabetes. The study’s primary objective 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.

In October 2012, the drug’s developer (Eli Lilly) announced positive top-line results from three other completed phase III AWARD trials: AWARD-1, AWARD-3, and AWARD-5. Primary efficacy endpoints, as measured by a reduction in HbA1c at the 1.5 mg dose, were met in all three studies.

Source: Eli Lilly; April 16, 2013.

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