作者
Bernard Zinman, Vanita R Aroda, John B Buse, Bertrand Cariou, Stewart B Harris, Søren Tetens Hoff, Karen Boje Pedersen, Mads Jeppe Tarp-Johansen, Eiichi Araki
发表日期
2019/12/1
期刊
Diabetes care
卷号
42
期号
12
页码范围
2262-2271
出版商
American Diabetes Association
简介
OBJECTIVE
To investigate the efficacy, safety, and tolerability of oral semaglutide added to insulin with or without metformin.
RESEARCH DESIGN AND METHODS
Patients with type 2 diabetes uncontrolled on insulin with or without metformin were randomized to oral semaglutide 3 mg (N = 184), 7 mg (N = 182), or 14 mg (N = 181) or to placebo (N = 184) in a 52-week, double-blind trial. End points were change from baseline to week 26 in HbA1c (primary) and body weight (confirmatory secondary). Two estimands were defined: treatment policy (effect regardless of trial product discontinuation or rescue medication) and trial product (effect assuming trial product continuation without rescue medication) in randomized patients.
RESULTS
Oral semaglutide was superior to placebo in reducing HbA1c (estimated treatment difference [ETD] –0.5% [95% CI –0.7, –0.3 …
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