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| |  LY2189265 Add-On Treatment Offers Positive Changes in Metabolic Effects in Overweight Patients With Type 2 Diabetes: Presented at IDF By Brian Hoyle MONTREAL -- October 23, 2009 -- Once-a-week subcutaneous injection of LY2189265 -- a novel and long-acting glucagon-like peptide-1 (GLP-1) analogue -- as an add-on treatment for overweight or obese patients with type 2 diabetes whose disease is not fully controlled using oral antihyperglycaemic (OAH) agents, produces substantial and significant decreases in the level of glycated haemoglobin (Hb A1C), body weight, and both postprandial glucose (PPG) and PPG excursion. The results, obtained as part of the Titration Effect of LY2189265 (GLP-1 Analog) Once Weekly (EGO) study were presented here on October 22 at the 20th World Diabetes Congress of the International Diabetes Federation (IDF) by Guillermo Umpierrez, MD, Emory University School of Medicine, Atlanta, Georgia. GLP-1 decreases secretion of glucagon from the pancreas, increases pancreatic secretion of insulin in a glucose-dependent fashion, and increases the mass and insulin gene expression of beta cells. This has prompted interest in the design and use of GLP-1 analogues such as LY2189265 as a therapy for diabetes. The randomised, multi-institutional, placebo-controlled, double-blind study investigated the metabolic influence of the once-weekly use of LY2189265 for 16 weeks in 262 overweight or clinically obese patients with uncontrolled type 2 diabetes (49% female, mean diabetes duration of 8.3 years, mean body mass index of 33.9 kg/m2, mean Hb A1C of 8.2%). Treatment emergent adverse events were also recorded. The patients were randomised to receive a once-weekly subcutaneous injection of placebo (n = 66) or LY2189265 (n = 196). Three LY2189265 dose regimens were used: 0.5 mg for 4 weeks then 1.0 mg for 12 weeks (0.5/1.0; n = 66), 1.0 mg for the full 16 weeks (1.0/1.0; n = 65), and 1.0 mg for 4 weeks then 2.0 mg for 12 weeks (1.0/2.0; n = 65). At the time they were randomised to treatment, all patients had a 3 month or longer history of use of 2 of 4 classes of OAH medication -- sulphonylurea, biguanide, thiazolidinedione, or dipeptidyl peptidase IV inhibitor. The main outcome was change from baseline values of Hb A1C at 16 weeks. Secondary outcomes measured were body weight, solid mixed meal test PPG, and PPG excursion. All 3 LY2189265 treatment regimens produced statistically significant metabolic outcomes, relative to placebo, for all measured metabolic outcomes (P < .05 for all). The 16 week change in Hb A1C was -1.3% (0.5/1.0), -1.3% (1.0/1.0), and -1.5% (1.0/2.0), as compared with -0.3% for placebo. Body weight change was -1.6% (0.5/1.0), -1.4% (1.0/1.0), and -2.5% (1.0/2.0), as compared with -0.1% for placebo. PPG values were 30.7 (0.5/1.0), 32.2 (1.0/1.0), 28.2 (1.0/2.0), and 36.4 for placebo. PPG excursion values were 8.9 (0.5/1.0), 9.9 (1.0/1.0), 8.2 (1.0/2.0), and 10.9 for placebo. Hypoglycaemia was not statistically significant across the treatment groups (overall P = .85), but the numbers of episodes were more in patients receiving LY2189265. No significant differences were evident concerning the most frequent treatment emergent adverse events of nausea (all treatments: 13%; P = .43), diarrhoea (8.8%; P = .45), and abdominal distension (8.0%; P = .26). “Further studies of longer duration will be needed to assess the possible additional benefits of LY2189265 therapy,” said Dr. Umpierrez. Funding for this study was provided by Eli Lilly. [Presentation title: Effect of LY2189265, a Long-Acting Glucagon-Like Peptide 1 Analog, on Metabolic Outcomes and GI Events in Obese Patients With Uncontrolled Type 2 Diabetes Mellitus (T2DM): The EGO Study. Abstract O-0543]
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