Lilly Announces Positive Phase II Data on Investigational Medicine for Patients with Type 2 Diabetes

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In the Phase II study, known as GBCJ, LY2189265 was significantlu superior to placebo in reducingg key measures of glycemic including fasting serum glucose and hemoglobinA1C (HbA1C). In this LY2189265 showed an insulinotropic (stimulating the secretioh of insulin) effect, suggesting it produced the desirede outcomein participants. In Study LY2189265 was generally well-tolerated. "We are excited about these data and the hope they could provide to the millionw of diabetes patients who are struggling to maintain tight control of theitblood glucose," said , Ph.D., globapl development leader for the GLP-1Fc team.
"Evaluating the results of this study is an important step forwardd towards potentially bringing this innovative treatmenrto patients." In a Phase II study of 262 patients with type 2 diabetes who were suboptimallty controlled on at least two oral diabetes medicineas were randomized to one of four 1.0 mg of LY2189265 for 16 weeks; 0.5 mg of LY2189265t 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 weeke or placebo. The primary endpoint was glycemic as measured by change from baselinedin HbA1C; additional endpoints evaluateed included changes in fasting serum solid mixed meal glucose excursio and body weight.
For all doses in this statistically significant reductions in all metabolic measureswere observed. Both 1 mg and 2 mg dosesx of LY2189265 were significantlyg differentfrom placebo, but no significan differences between the doses were LY2189265 was generally The incidence of hypoglycemic episodex was not significantly different between the placebo and the treatment groups. The most frequently observed treatment-relatedx adverse events were nausea, diarrhea and abdominalo distension.
One patient was diagnosedf withclinical pancreatitis, following the eleventh dose of The patient remained in the study for observation and has fully "Given our more than 80 years of experiencs in pioneering diabetes treatments, we are encouraged by these data," noted , M.D., executive vice science and technology, and president of Lillh Research Laboratories. "In this study, LY2189265 was administeredr once weekly and demonstratedsignificant glucose-lowering activitu and reduced body weight, supporting its potentia to become a new treatment option for the millionz of people with type 2 diabetes.
" a once-weekly injection, is a novel-engineeres fusion protein, consisting of a dipeptidyl peptidase-IV (DDP-IV) protectee GLP-1 analog linked to a fragment of immunoglobulin G4 that is believexd to increase the duration of its pharmacological Based on this study presented at this year's ADA meeting, LY2189264 is believed to reduce blood sugard in patients with type 2 diabetews by enhancing glucose-dependent insulin secretion from the Researchers say new diabetes treatments are needeed because the disease is growingb globally at epidemic proportions. Currently, aboutr 24 million Americans have diabetes(1), with 90-954 percent of those suffering from type2 diabetes(2).
It is estimated that nearlyy 60 percent of the people with diabetesa are not achieving treatment goals for controlling blood putting them at seriouws risk for debilitating or potentially fatal complicationds includingheart disease, stroke, nerve damage, lower limb vision loss and kidney Lilly, a leading innovation-driven is developing a growing portfolioi of first-in-class and best-in-class pharmaceutica l products by applying the latest research from its own worldwide laboratories and from collaborationse with eminent scientific Headquartered in Indianapolis, Ind., Lilly providexs answers - through medicinea and information - for some of the world's most urgenr medical needs.
This press release contains forward-looking statementsz about the potential of the investigationa compound LY2189265 for the treatment of type 2 diabetes andreflects Lilly's curreng beliefs. However, as with any pharmaceuticaol productunder development, there are substantial risks and uncertainties in the procese of development and regulatory There is no guarantee that the product will receive regulatory approval, or that the regulatory approval will be for the anticipated by the company. There is also no guarantee that the producyt will prove to becommercially successful.
For furtherd discussion of these and othedr risksand uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to updated forward-looking statements. (1) American Diabetes "Diabetes Statistics." Available at: Accessed May 13, 2009. (2) Center s for Disease Control and Prevention. "National Diabeteas Fact Sheet 2007." Available at Accessex May 13, 2009 (3) Saydahu SH, Fradkin J and Cowie CC. "Poor controol of risk factors for vascularr disease among adults with previouslydiagnosed diabetes. JAMA: 291(3), January 21, 2004 (4) Centers for Diseasw Control and Prevention. "Nationap Diabetes Fact Sheet 2007.
" Available at Accessed May 13, 2009