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Lilly's Investigational GLP-1 Receptor Agonist, Dulaglutide, Showed Superior Glycemic Control Versus Comparators In Patients With Type 2 Diabetes

CHICAGO, June 22, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today 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),[1] metformin (AWARD-3)[2] and sitagliptin (AWARD-5) in reducing  HbA1c (hemoglobin A1c) levels.[3] ,[4] 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.

Findings from these three AWARD trials, which tested dulaglutide 1.5 mg and 0.75 mg against comparators, were presented today at the 73 rd American Diabetes Association Scientific Sessions ® in Chicago.

"Dulaglutide not only demonstrated superior glycemic control in these Phase III trials, it provided this control with once-weekly dosing, which may be attractive to both patients and healthcare professionals," said Guillermo Umpierrez, M.D., professor of medicine, division of endocrinology, metabolism, Emory University School of Medicine, and chief of diabetes and endocrinology, Grady Memorial Hospital. "It's encouraging news for this investigational GLP-1 receptor agonist."

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.

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.

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