A 26-Week Randomized Controlled Trial of Semaglutide Once Daily Versus Liraglutide and Placebo in Patients With Type 2 Diabetes Suboptimally Controlled on Diet and Exercise With or Without Metformin

被引:62
作者
Lingvay, Ildiko [1 ]
Desouza, Cyrus V. [2 ]
Lalic, Katarina S. [3 ,4 ]
Rose, Ludger [5 ]
Hansen, Thomas [6 ]
Zacho, Jeppe [6 ]
Pieber, Thomas R. [7 ]
机构
[1] Univ Texas Southwestern Med Ctr Dallas, Dallas, TX 75390 USA
[2] Univ Nebraska Med Ctr, Omaha, NE USA
[3] Univ Belgrade, Fac Med, Belgrade, Serbia
[4] Clin Ctr Serbia, Clin Endocrinol Diabet & Metab Dis, Belgrade, Serbia
[5] Inst Diabet Res Munster, Munster, Germany
[6] Novo Nordisk AS, Soborg, Denmark
[7] Med Univ Graz, Graz, Austria
关键词
GLP-1; ANALOG; OPEN-LABEL; PHASE; 3A; ADD-ON; EFFICACY; GLUCOSE; SAFETY; ASSOCIATION; 56-WEEK;
D O I
10.2337/dc17-2381
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
OBJECTIVETo investigate the efficacy and safety of once-daily semaglutide in comparison with once-daily liraglutide and placebo in patients with type 2 diabetes.RESEARCH DESIGN AND METHODSThis 26-week, multicenter, double-blind trial involved patients diagnosed with type 2 diabetes with HbA(1c) 7.0-10.0% (53-86 mmol/mol) and treated with diet and exercise with or without metformin. Patients were randomized 2:2:1 to once-daily semaglutide, liraglutide, or placebo in one of four volume-matched doses (semaglutide 0.05, 0.1, 0.2, or 0.3 mg and liraglutide 0.3, 0.6, 1.2, or 1.8 mg, with both compared within each volume-matched dose group). Primary end point was change in HbA(1c) from baseline to week 26.RESULTSIn total, 705 randomized patients were exposed to trial products. At week 26, a dose-dependent change in HbA(1c) was observed with semaglutide from -1.1% (0.05 mg) to -1.9% (0.3 mg) and with liraglutide from -0.5% (0.3 mg) to -1.3% (1.8 mg) (all P < 0.001 in favor of volume-matched semaglutide dose). Change with pooled placebo was -0.02% (P < 0.0001 vs. semaglutide). Gastrointestinal (GI) disorders were the most common adverse events (AEs) with semaglutide and liraglutide, occurring in 32.8-54.0% and 21.9-41.5% of patients, respectively.CONCLUSIONSOnce-daily semaglutide at doses up to 0.3 mg/day resulted in greater reductions in HbA(1c) compared with liraglutide or placebo but with a higher frequency of GI AEs.
引用
收藏
页码:1926 / 1937
页数:12
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