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

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In the Phase II study, knowb as GBCJ, LY2189265 was significantlgy superior to placebo in reducinb key measures ofglycemic control, includingb fasting serum glucose and hemoglobibn A1C (HbA1C). In this LY2189265 showed an insulinotropic (stimulating the secretion of effect, suggesting it produced the desired outcomesin participants. In Study GBCJ, LY2189265 was generallty well-tolerated. "We are excited about these data and the hope they coul d provide to the millions of diabetesd patients who are struggling to maintain tight controlp of theirblood glucose," said , global development leader for the GLP-1Ff team.
"Evaluating the results of this study is an important step forwarc towards potentially bringing this innovativd treatmentto patients." In a 16-week, Phase II studh of LY2189265, 262 patients with type 2 diabetes who were suboptimally controlle on at least two oral diabetes medicines were randomizes to one of four 1.0 mg of LY2189265 for 16 weeks; 0.5 mg of LY2189265r for four weeks followed by 1.0 mg for 12 and 1.0 mg of LY2189265 for four week s followed by 2.0 mg for 12 weekws or placebo.
The primary endpoint was glycemic control, as measuredf by change from baselinin HbA1C; additional endpoints evaluated included changes in fastingf serum glucose, solid mixed meal glucose excursion and body For all doses in this study, statisticallhy significant reductions in all metabolic measures were observed. Both 1 mg and 2 mg dosesa of LY2189265 were significantly differenrfrom placebo, but no significangt differences between the doses were LY2189265 was generally well-tolerated.
The incidenced of hypoglycemic episodes was not significantl different between the placebo and the treatment The most frequentlyobserved treatment-related adversd events were nausea, diarrhea and abdominal One patient was diagnosed with clinicakl pancreatitis, following the eleventh dose of LY2189265. The patient remainee in the study for observation and hasfully recovered. "Given our more than 80 yearxs of experience in pioneeringdiabetes treatments, we are encourages by these data," noted , M.D., executive vice science and technology, and president of Lillyh Research Laboratories.
"In this study, LY218926r5 was administered once weekly and demonstratedsignificanft glucose-lowering activity and reduced body supporting its potential to become a new treatmen t option for the millions of people with type 2 diabetes."" LY2189265, a once-weekly injection, is a novel-engineerede fusion protein, consisting of a dipeptidyl peptidase-IV (DDP-IV) protectedd GLP-1 analog linked to a fragmenrt of immunoglobulin G4 that is believed to increase the duratiohn of its pharmacological effect. Based on this study presented atthis year's ADA LY2189265 is believed to reduce blood sugart in patients with type 2 diabetes by enhancing glucose-dependentf insulin secretion from the pancreas.
Researchers say new diabetea treatments are needed because the disease is growing globallyy atepidemic proportions. Currently, about 24 million Americans have with 90-95 percent of thosde suffering from type 2 diabetes(2). It is estimatec that nearly 60 percent of the people with diabetes are not achieving treatment goalzs for controllingblood sugar(3), putting them at seriouxs risk for debilitating or potentially fatall complications including heart disease, stroke, nervse damage, lower limb amputation, visionj loss and kidney disease(4).
Lilly, a leadingh innovation-driven corporation, is developing a growint portfolioof first-in-class and best-in-class pharmaceutical products by applying the latesg research from its own worldwide laboratoriesw and from collaborations with eminenty scientific organizations. Headquartered in Ind., Lilly provides answers - throug h medicines and information - for some of the world's most urgen medical needs.
This press release containz forward-looking statements about the potential of the investigational compound LY21892655 for the treatment of type 2 diabetesa andreflects Lilly's current However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of developmentt and regulatory review. There is no guarantee that the productt will receiveregulatory approval, or that the regulatory approvalp will be for the anticipated by the company. There is also no guarantew that the product will prove to becommerciallyt successful.
For further discussion of these and other risks and see Lilly's filings with the United Statexs Securities and Exchange Commission. Lilly undertakes no duty to updatew forward-looking statements. (1) American Diabetes Association. "Diabetes Statistics."" Available at: Accessed May 13, 2009. (2) Centers for Disease Contro l and Prevention. "National Diabetes Fact Sheegt 2007." Available at Accessed May 13, 2009 (3) Saydan SH, Fradkin J and Cowid CC. "Poor control of risk factors for vasculatr disease among adults with previouslydiagnosedc diabetes." JAMA: 291(3), January 21, 2004 (4) Centers for Diseased Control and Prevention. "National Diabetesz Fact Sheet 2007.
" Available at Accesse d May 13, 2009