INDIANAPOLIS (dpa-AFX) - Eli Lilly and Co. (LLY) announced detailed safety and efficacy results from three Phase III AWARD 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.
In the trials, dulaglutide 1.5 mg was superior to placebo and to exenatide (AWARD-1), metformin (AWARD-3) and sitagliptin (AWARD-5) in reducing HbA1c (hemoglobin A1c) levels. In addition, a greater percentage of patients treated with dulaglutide 1.5 mg achieved an HbA1c goal of less than 7 percent versus all active comparators.
In all three studies, patients taking dulaglutide 1.5 mg showed sustained weight loss for the duration of the trials. Patients taking dulaglutide 1.5 mg showed significant weight loss compared to patients taking sitagliptin (AWARD-5), and showed similar weight loss to patients taking comparators in AWARD-1 and AWARD-3.
Nausea was the most common adverse event reported across the studies for dulaglutide and was mostly mild to moderate and transient. No new safety signals were seen in any of the studies.
According to the company, Dulaglutide showed low rates of hypoglycemia (blood glucose level less than or equal to 70 mg/dL) across these three AWARD trials. There were no cases of documented severe hypoglycemia in any of the trials.
Lilly said it expects to submit dulaglutide to regulatory authorities in 2013 and to submit detailed data from two additional AWARD studies for presentation at scientific meetings in 2014.
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