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.
"These results are a promising step forward in our effort to provide a new, once-weekly GLP-1 treatment option, giving patients another choice to help manage their diabetes," said Sherry Martin, M.D., senior medical director, Lilly Diabetes. "Dulaglutide represents an important component of our diabetes portfolio, as it could help us offer a broader range of options to patients across the diabetes spectrum."
Dulaglutide is among several diabetes molecules in Lilly's late-stage pipeline. The company has a number of potential new medicines in clinical development for the treatment of diabetes and its related conditions, encompassing both large and small molecules, and targeting a variety of mechanisms. Lilly 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.
About the AWARD (Assessment of Weekly AdministRation of LY2189265 in Diabetes) Studies
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 1.5 mg, dosed once-weekly, is superior to placebo in reducing HbA1c from baseline at 26 weeks.
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 pati
|SOURCE Eli Lilly and Company|
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