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Lilly Announces Positive Phase II Data on Investigational Medicine for Patients with Type 2 Diabetes
Date:6/6/2009

NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) announced today new, positive Phase II study results of LY2189265, its investigational glucagon-like peptide 1 (GLP-1) analog administered subcutaneously once-weekly for the treatment of type 2 diabetes. These data will be presented as part of the American Diabetes Association's (ADA) 69th Annual Scientific Sessions.

In the Phase II study, known as GBCJ, LY2189265 was significantly superior to placebo in reducing key measures of glycemic control, including fasting serum glucose and hemoglobin A1C (HbA1C). In this study, LY2189265 showed an insulinotropic (stimulating the secretion of insulin) effect, suggesting it produced the desired outcome in participants. In Study GBCJ, LY2189265 was generally well-tolerated.

"We are excited about these data and the hope they could provide to the millions of diabetes patients who are struggling to maintain tight control of their blood glucose," said Pawel Fludzinski, Ph.D., global development leader for the GLP-1Fc team. "Evaluating the results of this study is an important step forward towards potentially bringing this innovative treatment to patients."

About Study GBCJ

In a 16-week, Phase II study of LY2189265, 262 patients with type 2 diabetes who were suboptimally controlled on at least two oral diabetes medicines were randomized to one of four arms: 1.0 mg of LY2189265 for 16 weeks; 0.5 mg of LY2189265 for four weeks followed by 1.0 mg for 12 weeks; and 1.0 mg of LY2189265 for four weeks followed by 2.0 mg for 12 weeks or placebo. The primary endpoint was glycemic control, as measured by change from baseline in HbA1C; additional endpoints evaluated included changes in fasting serum glucose, solid mixed meal glucose excursion and body weight.

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