Oral Semaglutide Versus Empagliflozin in Patients With Type 2 Diabetes Uncontrolled on Metformin: The PIONEER 2 Trial

赛马鲁肽 恩帕吉菲 医学 2型糖尿病 二甲双胍 中止 随机对照试验 糖尿病 内科学 胃肠病学 泌尿科 利拉鲁肽 内分泌学
作者
Helena W. Rodbard,Julio Rosenstock,Luís Henrique Santos Canani,Chaicharn Deerochanawong,Janusz Gumprecht,Søren Lindberg,Ildiko Lingvay,ANETTE L. SØNDERGAARD,Marianne Bach Treppendahl,Eduard Montanya,Pablo Jordão Alcântara Cruz,Luis De Loredo,Cecilia Luquez,Maria Alejandra Moisello,Gustavo Akerman Augusto,Marise Lazaretti Castro,Luís Henrique Santos Canani,Branko Akrap,Tomislav Bulum,Dario Rahelić
出处
期刊:Diabetes Care [American Diabetes Association]
卷期号:42 (12): 2272-2281 被引量:314
标识
DOI:10.2337/dc19-0883
摘要

Efficacy and safety of the glucagon-like peptide 1 (GLP-1) analog oral semaglutide and the sodium-glucose cotransporter 2 inhibitor empagliflozin were compared in patients with type 2 diabetes uncontrolled on metformin.Patients were randomized to once-daily open-label treatment with oral semaglutide 14 mg (n = 412) or empagliflozin 25 mg (n = 410) in a 52-week trial. Key end points were change from baseline to week 26 in HbA1c (primary) and body weight (confirmatory secondary). Two estimands addressed efficacy-related questions: treatment policy (regardless of trial product discontinuation or rescue medication) and trial product (on trial product without rescue medication) in all randomized patients.Four hundred (97.1%) patients in the oral semaglutide group and 387 (94.4%) in the empagliflozin group completed the trial. Oral semaglutide provided superior reductions in HbA1c versus empagliflozin at week 26 (treatment policy -1.3% vs. -0.9% [-14 vs. -9 mmol/mol], estimated treatment difference [ETD] -0.4% [95% CI -0.6, -0.3] [-5 mmol/mol (-6, -3)]; P < 0.0001). The treatment difference in HbA1c significantly favored oral semaglutide at week 26 for the trial product estimand (-1.4% vs. -0.9% [-15 vs. -9 mmol/mol], ETD -0.5% [95% CI -0.7, -0.4] [-6 mmol/mol (-7, -5)]; P < 0.0001) and at week 52 for both estimands (P < 0.0001). Superior weight loss was not confirmed at week 26 (treatment policy), but oral semaglutide was significantly better than empagliflozin at week 52 (trial product -4.7 vs. -3.8 kg; P = 0.0114). Gastrointestinal adverse events were more common with oral semaglutide.Oral semaglutide was superior to empagliflozin in reducing HbA1c but not body weight at 26 weeks in patients with type 2 diabetes uncontrolled on metformin. At week 52, HbA1c and body weight (trial product estimand) were significantly reduced versus empagliflozin. Oral semaglutide was well tolerated within the established safety profile of GLP-1 receptor agonists.
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