To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ADA: Prandin (Repaglinide) Allows Flexible Mealtime Regimens For Diabetics Without Affecting Body Weight URL: http://www.pslgroup.com/dg/1D534A.htm Doctor's Guide June 12, 2000
SAN ANTONIO, TX -- June 12, 2000 -- Clinical data show that the oral antidiabetic drug (OAD) Prandin® (repaglinide) Tablets in a flexible mealtime regimen improved glycemic control without significantly increasing body weight in patients with type 2 diabetes was presented at the annual meeting of the American Diabetes Association. "The study suggests that the flexible mealtime response of Prandin may limit weight gain while achieving glycemic control," said investigator, Robert Moses, M.D., Director of Diabetes, University of Wollonggong, South Wales Australia. Prandin belongs to a unique class of insulin secretagogues called meglitinides and is characterized by a rapid stimulation of insulin secretion, which makes it particularly well suited for mealtime dosing when rapid release of insulin is required. Weight gain is known to be associated with the metabolic activity of insulin; theoretically, long-acting insulin secretagogues may have a similar effect, increasing basal insulin production with related increase in appetite and anabolism. Dr. Moses says, "This may be compounded by the need to consume regular meals supplemented by snacks to counteract the risk of hypoglycemia inherent in some sulfonylurea regimens." Dr. Moses adds, "It is anticipated that treatments designed to manage diabetes by selectively stimulating the prandial insulin response may have a low propensity for causing weight gain; basal insulin output is not increased, and the consequent reduction in the risk of hypoglycemia reduces the need for snacking." In this 16-week, multicenter, double-blind, prospective, placebo-controlled parallel-group study, the effect of prandial glucose regulation with repaglinide on body weight was assessed, when patients were free to follow a flexible meal schedule. Patients with type 2 diabetes new to oral hypoglycemic therapy were randomized in a 2:1 ratio to receive Prandin, 0.5-1.0 mg (n = 270) or placebo (n = 138), taken immediately prior to main meals. Patients ate two, three or four main meals per day at whatever time they wished and were free to vary their meal pattern on a day-to-day basis. Patients randomized to Prandin showed a significant improvement in glycemic control, with decreases in HbA1c of 1.14 percentage points and fasting blood glucose of 1.73 mmol/l, (both p < 0.05). These improvements were achieved without an increase in body weight (mean body weight change, + 0.35 kg n.s.), and irrespective of the meal pattern chosen. Patients receiving placebo showed no improvement in glycemic control, but a small yet significant (p < 0.05) mean decrease in body weight 0.75 kg. There was no clinically significant weight gain in long-term clinical trials with Prandin(1). In clinical trials, the most common adverse events leading to discontinuation were hyperglycemia, hypoglycemia, and related symptoms. The most common adverse events reported were cold- and flu-like symptoms, headache, diarrhea, joint ache and back pain. (1) Reference data from five 1-year trials comparing Prandin (n=1199) and sulfonylureas (n=582). --------------------------------------------------------------------------------------------- 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.