作者
Julio Rosenstock, Dale Allison, Andreas L Birkenfeld, Thalia Marie Blicher, Srikanth Deenadayalan, Jacob Bonde Jacobsen, Pierre Serusclat, Rafael Violante, Hirotaka Watada, Melanie Davies, PIONEER 3 Investigators
发表日期
2019/4/16
期刊
Jama
卷号
321
期号
15
页码范围
1466-1480
出版商
American Medical Association
简介
Importance
Phase 3 trials have not compared oral semaglutide, a glucagon-like peptide 1 receptor agonist, with other classes of glucose-lowering therapy.
Objective
To compare efficacy and assess long-term adverse event profiles of once-daily oral semaglutide vs sitagliptin, 100 mg added on to metformin with or without sulfonylurea, in patients with type 2 diabetes.
Design, Setting, and Participants
Randomized, double-blind, double-dummy, parallel-group, phase 3a trial conducted at 206 sites in 14 countries over 78 weeks from February 2016 to March 2018. Of 2463 patients screened, 1864 adults with type 2 diabetes uncontrolled with metformin with or without sulfonylurea were randomized.
Interventions
Patients were randomized to receive once-daily oral semaglutide, 3 mg (n = 466), 7 mg (n = 466), or 14 mg (n = 465), or sitagliptin, 100 mg (n = 467). Semaglutide was initiated at 3 mg/d and escalated …
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