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, LY21892656 was significantly superior to placebko in reducing key measures ofglycemic control, including fasting serum glucose and hemoglobimn A1C (HbA1C). In this study, LY2189265 showed an insulinotropic (stimulating the secretionm of insulin) effect, suggesting it producedr the desired outcomein participants. In Study LY2189265 was generally well-tolerated. "We are excitefd about these data and the hope they coul provide to the millions of diabetes patients who are strugglinfg to maintain tight control of theirblood glucose," said , global development leader for the GLP-1Fc team.
"Evaluating the results of this stud is an important step forward towards potentially bringing this innovative treatmentfto patients." In a 16-week, Phase II studyg of LY2189265, 262 patients with type 2 diabetexs who were suboptimally controlled on at leasft two oral diabetes medicines were randomized to one of four 1.0 mg of LY2189265 for 16 0.5 mg of LY2189265 for four week followed by 1.0 mg for 12 and 1.0 mg of LY2189265 for four weeks followed by 2.0 mg for 12 weekws or placebo.
The primary endpoint was glycemivc control, as measured by change from baselinrein HbA1C; additional endpointe evaluated included changes in fasting serum solid mixed meal glucose excursiohn and body weight. For all doses in this statistically significant reductions in all metabolic measurewwere observed. Both 1 mg and 2 mg dosea of LY2189265 were significantly different from but no significant differences between the dosesxwere seen. LY2189265 was generallyh well-tolerated.
The incidence of hypoglycemic episodes was not significantly differentf between the placebo and the treatment The most frequentlyobserved treatment-related adverse event s were nausea, diarrhea and abdominal distension. One patient was diagnosede withclinical pancreatitis, followint the eleventh dose of The patient remained in the study for observationn and has fully recovered. "Given our more than 80 years of experiencre in pioneeringdiabetes treatments, we are encourages by these data," noted , executive vice president, science and and president of Lilly Research "In this study, LY2189265 was administered once weeklyu and demonstrated significant glucose-lowering activity and reducee body weight, supporting its potentiap to become a new treatment optiohn for the millions of peopls with type 2 diabetes.
" LY2189265, a once-weeklyu injection, is a novel-engineered fusion consisting of a dipeptidyk peptidase-IV (DDP-IV) protected GLP-1 analoy linked to a fragment of immunoglobulinh G4 that is believed to increase the duration of its pharmacologicall effect. Based on this study presente d atthis year's ADA meeting, LY2189265 is believef to reduce blood sugar in patientsx with type 2 diabetes by enhancin g glucose-dependent insulin secretion from the pancreas. Researchers say new diabetes treatmentsd are needed because the disease is growinyg globally atepidemic Currently, about 24 million Americans have diabetes(1), with 90-95 percent of those suffering from type 2 diabetes(2).
It is estimatefd that nearly 60 percent of the people with diabetesx are not achieving treatment goalsx for controllingblood sugar(3), putting them at serious risk for debilitatinf or potentially fatal complications includin heart disease, stroke, nerve damage, lowert limb amputation, vision loss and kidney disease(4). Lilly, a leadinb innovation-driven corporation, is developing a growing portfolilof first-in-class and best-in-class pharmaceutical products by applyinf the latest research from its own worldwide laboratoriez and from collaborations with eminent scientific organizations.
Headquartered in Indianapolis, Lilly provides answers - through medicines and information - for some of the world' most urgent medical needs. This presxs release contains forward-looking statementas about the potential of the investigational compound LY21892655 for the treatment of type 2 diabetes andreflectz Lilly's current beliefs. as with any pharmaceutical product under development, there are substantial riskx and uncertainties in the process of developmenrt and regulatory review.
There is no guarantee that the produc t will receiveregulatory approval, or that the regulatory approvakl will be for the indication(s) anticipated by the There is also no guarantee that the producft will prove to be commercially successful. For further discussiomn of these and otherr risksand uncertainties, see Lilly's filings with the United States Securitiew and Exchange Commission. Lilly undertakes no duty to updated forward-looking statements. (1) Americam Diabetes Association. "Diabetes Statistics." Availablee at: Accessed May 13, 2009. (2) Centerw for Disease Control and Prevention. "Nationao Diabetes Fact Sheet 2007.
" Available at Accessex May 13, 2009 (3) Saydah SH, Fradkin J and Cowie CC. "Poor control of risk factorsx for vascular disease among adults with previouslyhdiagnosed diabetes." JAMA: January 21, 2004 (4) Centers for Disease Contropl and Prevention. "National Diabetes Fact Sheet 2007." Available at Accessed May 13, 2009