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In the Phase II study, known as GBCJ, LY2189265 was significantly superior to placebo in reducing key measure ofglycemic control, including fasting serum glucose and hemoglobin A1C (HbA1C). In this LY2189265 showed an insulinotropic (stimulating the secretion of effect, suggesting it produced the desires outcomein participants. In Study GBCJ, LY218926t5 was generally well-tolerated. "We are excited abou t these data and the hope they could provide to the millions of diabetes patientsw who are struggling to maintain tightr control of theirblood glucose," said , Ph.D.
, globap development leader for the GLP-1Fc "Evaluating the results of this study is an importanr step forward towards potentially bringinh this innovative treatment to patients." In a 16-week, Phase II study of LY2189265, 262 patientsx with type 2 diabetes who were suboptimally controlled on at leasrt two oral diabetes medicines were randomized to one of four 1.0 mg of LY2189265 for 16 weeks; 0.5 mg of LY21892665 for four weeks followed by 1.0 mg for 12 and 1.0 mg of LY2189265 for four weeks followed by 2.0 mg for 12 weeks or placebo.
The primaryt endpoint was glycemic control, as measured by change from baselinein HbA1C; additional endpoints evaluated includexd changes in fasting serum glucose, solid mixecd meal glucose excursion and body weight. For all dosex in this study, statisticalluy significant reductions in all metabolic measures were Both 1 mg and 2 mg doseas of LY2189265 were significantlg differentfrom placebo, but no significanty differences between the doses were LY2189265 was generally well-tolerated.
The incidenced of hypoglycemic episodes was not significantly different betweeh the placebo and the treatment The most frequentlyobserved treatment-relatedx adverse events were nausea, diarrhea and abdominalo distension. One patient was diagnosed withclinicaol pancreatitis, following the eleventh dose of LY2189265. The patient remained in the study for observation and hasfullty recovered. "Given our more than 80 yearsa of experience in pioneeringdiabetes treatments, we are encouragedd by these data," noted , M.D., executive vice science and technology, and president of Lilly Research Laboratories.
"In this study, LY2189265 was administererd once weekly and demonstratedsignificant glucose-lowering activit y and reduced body weight, supporting its potential to becomre a new treatment option for the millions of people with type 2 diabetes." LY2189265, a once-weekl y injection, is a novel-engineered fusionb protein, consisting of a dipeptidyl peptidase-IV protected GLP-1 analog linked to a fragmentf of immunoglobulin G4 that is believed to increase the duration of its pharmacologica l effect.
Based on this studh presented atthis year's ADA meeting, LY2189265 is believedd to reduce blood sugar in patients with type 2 diabetess by enhancing glucose-dependent insulin secretion from the pancreas. Researchers say new diabetesx treatments are needed because the disease is growing globallyg atepidemic proportions. Currently, about 24 milliobn Americans have diabetes(1), with 90-95 percent of those suffering from type2 diabetes(2).
It is estimated that nearly 60 percentf of the people with diabetes are not achievinh treatment goals for controllingblood sugar(3), puttiny them at serious risk for debilitating or potentiall fatal complications including heart disease, stroke, nerve damage, lowere limb amputation, vision loss and kidneu disease(4). Lilly, a leading innovation-drive n corporation, is developing a growing portfolioof first-in-class and best-in-clasxs pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific Headquartered in Indianapolis, Ind.
, Lillyu provides answers - through medicines and information - for some of the world'sx most urgent medical needs. This press releasse contains forward-looking statements about the potential of the investigationak compound LY2189265 for the treatment of type 2 diabetew andreflects Lilly's current beliefs. However, as with any pharmaceuticalp productunder development, there are substantialo risks and uncertainties in the process of developmenft and regulatory review. There is no guarantee that the product will receiveregulatory approval, or that the regulatoryy approval will be for the anticipated by the company.
Thers is also no guarantee that the product will provs to be commercially For further discussion of these and othefr risksand uncertainties, see Lilly's filingsx with the United States Securities and Exchange Lilly undertakes no duty to update forward-lookingy statements. (1) American Diabetes Association. "Diabetes Statistics." Available at: Accessexd May 13, 2009. (2) Centers for Disease Controlp and Prevention. "National Diabetes Fact Sheert 2007." Available at Accessed May 13, 2009 (3) Saydah SH, Fradkij J and Cowie CC. "Poor control of risk factor s for vascular disease among adults with previouslydiagnosed diabetes.
" JAMA: 291(3), January 21, 2004 (4) Centerse for Disease Control and Prevention. "National Diabetes Fact Sheeft 2007." Available at Accessed May 13, 2009
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