To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Once-Weekly Exenatide Tops Twice-Daily Formulation for Glycaemic Control: Presented at EASD URL: http://www.pslgroup.com/dg/22BBBA.htm Doctor's Guide September 10, 2008
By Jill Stein ROME -- September 10, 2008 -- New results show that once-weekly exenatide produces larger improvements in glycaemic control in patients with type 2 diabetes than twice-daily exenatide, with a similar safety and tolerability profile and similar decrease in body weight at 52 weeks. Thirty-week data from the trial were published online in the September 8 issue of The Lancet while follow-up 22-week data from an open-ended treatment phase were released on September 10 here at the European Association for the Study of Diabetes (EASD) 2008.(1) Daniel Drucker, MD, Mount Sinai Hospital, and the University of Toronto, Toronto, Ontario, and colleagues evaluated 295 patients who had been randomised to 30 weeks of treatment with the glucagon-like peptide 1 receptor activator exenatide 2 mg administered once weekly or exenatide 10 mcg administered twice a day. Participants in the trial participated in a dietary modification and exercise program or drug treatment with metformin, a sulfonylurea, a thiazolidinedione, or any combination of these agents. The primary endpoint was change in haemoglobin (Hb) A1C at 30 weeks. At 30 weeks, patients treated with once-weekly exenatide had a mean Hb A1C of 6.4% (a 1.9% decrease) while patients assigned to the twice-daily formulation had a mean Hb A1C of 6.8% (a 1.5% decrease, P = .0023). Also, 77% of patients who received exenatide once a week achieved Hb A1C levels of 7% or less at the end of treatment, from a mean baseline Hb A1C >8%. In patients with a baseline Hb A1C >9%, nearly two-thirds achieved an Hb A1C level <=7%. Body weight decreased progressively in both groups throughout treatment, with a mean weight loss of 3.7 kg in the once-weekly group and 3.6 kg in the twice-daily group. Both treatments were generally well tolerated, with withdrawal rates secondary to treatment averaging about 5% in both groups. The once-weekly formulation did not confer an increased risk of hypoglycaemia. At the end of the 30-week trial, 258 patients entered a 22-week, open-ended treatment phase with once-weekly exenatide. During his presentation on September 10 at the EASD meeting, co-investigator Jon Buse, MD, University of North Carolina, Chapel Hill, North Carolina, reported that improvements in both Hb A1C and fasting plasma glucose (FPG) were maintained in patients on once-weekly exenatide for 52 weeks (Hb A1C: -2.0 +- 0.1%; FPG: -2.6 +- 0.2 mmol/L), while patients who switched from the twice-weekly to once-daily formulation achieved similar glycaemic control by week 52 (Hb A1C: -2.0 +- 0.1%; FPG: -2.4 +- 0.2 mmol/L). In both groups, about 75% of patients achieved an Hb A1C value of <=7%, and about half achieved the more rigorous target of <=6.5%. Both treatment cohorts had a mean weight loss of 4 kg at 52 weeks. Given the complexity of present diabetes treatment options that call for once- or twice-daily administration of therapeutic agents, the significant improvement in Hb A1C coupled with the weight loss seen with the once-daily exenatide suggest that continuous glucagon-like peptide 1 receptor activation represents a valuable treatment choice for the management of type 2 diabetes, Dr. Drucker and colleagues wrote in their article. Funding for this study was provided by Amylin Pharmaceuticals and Eli Lilly and Company. 1. Drucker DJ et al. [Published online ahead of print September 8, 2008]. The Lancet. doi:10.1016/S0140-6736(08)61206-4. [Presentation title: Exenatide Once Weekly Elicits Sustained Glycemic Control and Weight Loss Over 52 Weeks. Abstract 146] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.