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

INDIANAPOLIS, Oct. 22, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive top-line results of three completed Phase III AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) analog being studied as a once-weekly treatment for type 2 diabetes. Primary efficacy endpoints, as measured by reduction in hemoglobin A1c (HbA1c) at the 1.5 mg dose, were met in three studies (AWARD-1, AWARD-3 and AWARD-5).  Having met the primary endpoints, superiority for HbA1c lowering was examined, and both doses of dulaglutide (0.75mg and 1.5mg) demonstrated statistically superior reduction in HbA1c from baseline compared to: exenatide twice-daily injection at 26 weeks (AWARD-1); metformin at 26 weeks (AWARD-3); and sitagliptin at 52 weeks (AWARD-5).

Across the three completed AWARD studies, the most frequently reported adverse events were gastrointestinal-related. These adverse event findings are consistent with prior studies of dulaglutide.

There are a number of additional AWARD ( Assessment of Weekly Administ Ration of LY2189265 in Diabetes) trials ongoing. Two of these studies for submission, AWARD-2 and AWARD-4, will conclude in the next few months.

"We're very encouraged by the results to date from our Phase III dulaglutide trials and are pleased to be one step closer to offering a new GLP-1 treatment option for type 2 diabetes," said Enrique Conterno, President, Lilly Diabetes. "People with diabetes require different treatment options based on their individual needs. That's why Lilly Diabetes is committed to delivering a broad, comprehensive portfolio of therapies."

Lilly plans to present detailed data from the AWARD studies at scientific meetings in 2013 and 2014.  The company expects to submit dulaglutide to regulatory authorities during 2013 with the timing of regulatory submission in the United States dependent upon satisfactory completion of U.S. Food and Drug Administration requirements for assessment of cardiovascular risk.

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, was superior to placebo in reducing HbA1c from baseline at 26 weeks.

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