AIMS: To evaluate the efficacy of exenatide in Asian patients with type 2 diabetes (T2D) inadequately controlled with oral agents. METHODS: Patients taking metformin (MET) alone or with a sulphonylurea (SU) were randomly assigned to exenatide 5 microg then 10 microg twice-daily for 4 and 12 weeks, respectively, or placebo. The primary endpoint was baseline to endpoint HbA(1c) change. RESULTS:466 patients (age 54+/-9 years, weight 68.7+/-11.2 kg, BMI 26.3+/-3.3 kg/m(2), and HbA(1c) 8.3+/-1.1%; mean+/-S.D.) were enrolled in the full analysis set. Endpoint HbA(1c) reduction (mean [95% CI]) with exenatide was superior to placebo (-1.2 [-1.3, -1.1]% vs. -0.4 [-0.5, -0.2]%, p<0.001). More exenatide- than placebo-treated patients achieved HbA(1c) <or=7% (48% vs. 17%, p<0.001). At endpoint, weight reduction was greater with exenatide (-1.2 [-1.5, -0.9]kg) than placebo (-0.1 [-0.3, 0.2]kg), p<0.001. Nausea, generally mild-to-moderate, was the most common adverse event with exenatide (25% vs. 1% with placebo). The incidence of symptomatic hypoglycaemia with exenatide and placebo were 36% and 9%, respectively (p<0.001). Hypoglycaemia rates (events/patient-year) for patients taking exenatide with MET or MET and SU were 1.8 (0.9, 3.7) and 4.7 (3.5, 6.5), respectively. CONCLUSION: Exenatide treatment improved glycaemic control in Asian patients with T2D and had a similar safety profile as in non-Asian patients.
RCT Entities:
AIMS: To evaluate the efficacy of exenatide in Asian patients with type 2 diabetes (T2D) inadequately controlled with oral agents. METHODS:Patients taking metformin (MET) alone or with a sulphonylurea (SU) were randomly assigned to exenatide 5 microg then 10 microg twice-daily for 4 and 12 weeks, respectively, or placebo. The primary endpoint was baseline to endpoint HbA(1c) change. RESULTS: 466 patients (age 54+/-9 years, weight 68.7+/-11.2 kg, BMI 26.3+/-3.3 kg/m(2), and HbA(1c) 8.3+/-1.1%; mean+/-S.D.) were enrolled in the full analysis set. Endpoint HbA(1c) reduction (mean [95% CI]) with exenatide was superior to placebo (-1.2 [-1.3, -1.1]% vs. -0.4 [-0.5, -0.2]%, p<0.001). More exenatide- than placebo-treated patients achieved HbA(1c) <or=7% (48% vs. 17%, p<0.001). At endpoint, weight reduction was greater with exenatide (-1.2 [-1.5, -0.9]kg) than placebo (-0.1 [-0.3, 0.2]kg), p<0.001. Nausea, generally mild-to-moderate, was the most common adverse event with exenatide (25% vs. 1% with placebo). The incidence of symptomatic hypoglycaemia with exenatide and placebo were 36% and 9%, respectively (p<0.001). Hypoglycaemia rates (events/patient-year) for patients taking exenatide with MET or MET and SU were 1.8 (0.9, 3.7) and 4.7 (3.5, 6.5), respectively. CONCLUSION:Exenatide treatment improved glycaemic control in Asian patients with T2D and had a similar safety profile as in non-Asian patients.
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