OBJECTIVE: To determine the effect of a lifestyle modification program plus exenatide versus lifestyle modification program plus placebo on weight loss in overweight or obese participants with type 2 diabetes treated withmetformin and/or sulfonylurea. METHODS: In this 24-week, multicenter, randomized, double-blind, placebo-controlled study, 194 patients participated in a lifestyle modification program, consisting of goals of 600 kcal/day deficit and physical activity of at least 2.5 hours/week. Participants were randomized to 5 microg exenatide twice daily injection + lifestyle modification program (n = 96) or placebo + lifestyle modification program (n = 98), and after 4 weeks increased their exenatide dose to 10 microg twice daily or volume equivalent of placebo. RESULTS: Baseline characteristics: (mean +/- standard deviation) age, 54.8 +/- 9.5 years; weight, 95.5 +/- 16.0 kg; hemoglobin A(1c), 7.6 +/- 0.8%. At 24 weeks (least squares mean +/- standard error), treatments showed similar decreases in caloric intake (-378 +/- 58 vs -295 +/- 58 kcal/day, exenatide + lifestyle modification program vs placebo + lifestyle modification program, P = .27) and increases in exercise-derived energy expenditure. Exenatide + lifestyle modification program showed greater change in weight (-6.16 +/- 0.54 kg vs -3.97 +/- 0.52 kg, P = .003), hemoglobin A(1c) (-1.21 +/- 0.09% vs -0.73 +/- 0.09%, P <.0001), systolic (-9.44 +/- 1.40 vs -1.97 +/- 1.40 mm Hg, P <.001) and diastolic blood pressure (-2.22 +/- 1.00 vs 0.47 +/- 0.99 mm Hg, P = .04). Nausea was reported more for exenatide + lifestyle modification program than placebo + lifestyle modification program (44.8% vs 19.4%, respectively, P <.001), with no difference in withdrawal rates due to adverse events (4.2% vs 5.1%, respectively, P = 1.0) or rates of hypoglycemia. CONCLUSIONS: When combined with lifestyle modification, exenatide treatment led to significant weight loss, improved glycemic control, and decreased blood pressure compared with lifestyle modification alone in overweight or obese participants with type 2 diabetes on metformin and/or sulfonylurea treatment. Copyright 2010 Elsevier Inc. All rights reserved.
RCT Entities:
OBJECTIVE: To determine the effect of a lifestyle modification program plus exenatide versus lifestyle modification program plus placebo on weight loss in overweight or obeseparticipants with type 2 diabetes treated with metformin and/or sulfonylurea. METHODS: In this 24-week, multicenter, randomized, double-blind, placebo-controlled study, 194 patients participated in a lifestyle modification program, consisting of goals of 600 kcal/day deficit and physical activity of at least 2.5 hours/week. Participants were randomized to 5 microg exenatide twice daily injection + lifestyle modification program (n = 96) or placebo + lifestyle modification program (n = 98), and after 4 weeks increased their exenatide dose to 10 microg twice daily or volume equivalent of placebo. RESULTS: Baseline characteristics: (mean +/- standard deviation) age, 54.8 +/- 9.5 years; weight, 95.5 +/- 16.0 kg; hemoglobin A(1c), 7.6 +/- 0.8%. At 24 weeks (least squares mean +/- standard error), treatments showed similar decreases in caloric intake (-378 +/- 58 vs -295 +/- 58 kcal/day, exenatide + lifestyle modification program vs placebo + lifestyle modification program, P = .27) and increases in exercise-derived energy expenditure. Exenatide + lifestyle modification program showed greater change in weight (-6.16 +/- 0.54 kg vs -3.97 +/- 0.52 kg, P = .003), hemoglobin A(1c) (-1.21 +/- 0.09% vs -0.73 +/- 0.09%, P <.0001), systolic (-9.44 +/- 1.40 vs -1.97 +/- 1.40 mm Hg, P <.001) and diastolic blood pressure (-2.22 +/- 1.00 vs 0.47 +/- 0.99 mm Hg, P = .04). Nausea was reported more for exenatide + lifestyle modification program than placebo + lifestyle modification program (44.8% vs 19.4%, respectively, P <.001), with no difference in withdrawal rates due to adverse events (4.2% vs 5.1%, respectively, P = 1.0) or rates of hypoglycemia. CONCLUSIONS: When combined with lifestyle modification, exenatide treatment led to significant weight loss, improved glycemic control, and decreased blood pressure compared with lifestyle modification alone in overweight or obeseparticipants with type 2 diabetes on metformin and/or sulfonylurea treatment. Copyright 2010 Elsevier Inc. All rights reserved.
Authors: Robert A Scott; Daniel F Freitag; Li Li; Audrey Y Chu; Praveen Surendran; Robin Young; Niels Grarup; Alena Stancáková; Yuning Chen; Tibor V Varga; Hanieh Yaghootkar; Jian'an Luan; Jing Hua Zhao; Sara M Willems; Jennifer Wessel; Shuai Wang; Nisa Maruthur; Kyriaki Michailidou; Ailith Pirie; Sven J van der Lee; Christopher Gillson; Ali Amin Al Olama; Philippe Amouyel; Larraitz Arriola; Dominique Arveiler; Iciar Aviles-Olmos; Beverley Balkau; Aurelio Barricarte; Inês Barroso; Sara Benlloch Garcia; Joshua C Bis; Stefan Blankenberg; Michael Boehnke; Heiner Boeing; Eric Boerwinkle; Ingrid B Borecki; Jette Bork-Jensen; Sarah Bowden; Carlos Caldas; Muriel Caslake; L Adrienne Cupples; Carlos Cruchaga; Jacek Czajkowski; Marcel den Hoed; Janet A Dunn; Helena M Earl; Georg B Ehret; Ele Ferrannini; Jean Ferrieres; Thomas Foltynie; Ian Ford; Nita G Forouhi; Francesco Gianfagna; Carlos Gonzalez; Sara Grioni; Louise Hiller; Jan-Håkan Jansson; Marit E Jørgensen; J Wouter Jukema; Rudolf Kaaks; Frank Kee; Nicola D Kerrison; Timothy J Key; Jukka Kontto; Zsofia Kote-Jarai; Aldi T Kraja; Kari Kuulasmaa; Johanna Kuusisto; Allan Linneberg; Chunyu Liu; Gaëlle Marenne; Karen L Mohlke; Andrew P Morris; Kenneth Muir; Martina Müller-Nurasyid; Patricia B Munroe; Carmen Navarro; Sune F Nielsen; Peter M Nilsson; Børge G Nordestgaard; Chris J Packard; Domenico Palli; Salvatore Panico; Gina M Peloso; Markus Perola; Annette Peters; Christopher J Poole; J Ramón Quirós; Olov Rolandsson; Carlotta Sacerdote; Veikko Salomaa; María-José Sánchez; Naveed Sattar; Stephen J Sharp; Rebecca Sims; Nadia Slimani; Jennifer A Smith; Deborah J Thompson; Stella Trompet; Rosario Tumino; Daphne L van der A; Yvonne T van der Schouw; Jarmo Virtamo; Mark Walker; Klaudia Walter; Jean E Abraham; Laufey T Amundadottir; Jennifer L Aponte; Adam S Butterworth; Josée Dupuis; Douglas F Easton; Rosalind A Eeles; Jeanette Erdmann; Paul W Franks; Timothy M Frayling; Torben Hansen; Joanna M M Howson; Torben Jørgensen; Jaspal Kooner; Markku Laakso; Claudia Langenberg; Mark I McCarthy; James S Pankow; Oluf Pedersen; Elio Riboli; Jerome I Rotter; Danish Saleheen; Nilesh J Samani; Heribert Schunkert; Peter Vollenweider; Stephen O'Rahilly; Panos Deloukas; John Danesh; Mark O Goodarzi; Sekar Kathiresan; James B Meigs; Margaret G Ehm; Nicholas J Wareham; Dawn M Waterworth Journal: Sci Transl Med Date: 2016-06-01 Impact factor: 17.956