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

Diabetes Care
Ildiko LingvayThomas R Pieber

Abstract

To investigate the efficacy and safety of once-daily semaglutide in comparison with once-daily liraglutide and placebo in patients with type 2 diabetes. This 26-week, multicenter, double-blind trial involved patients diagnosed with type 2 diabetes with HbA1c 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 HbA1c from baseline to week 26. In total, 705 randomized patients were exposed to trial products. At week 26, a dose-dependent change in HbA1c 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. Once-daily semaglutide at doses up ...Continue Reading

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Citations

Feb 16, 2019·Obesity Reviews : an Official Journal of the International Association for the Study of Obesity·Georgios A ChristouDimitrios N Kiortsis
May 31, 2019·Metabolic Syndrome and Related Disorders·Ajay Sood, Arthur Swislocki
Oct 28, 2019·Diabetes, Obesity & Metabolism·Louis S MatzaLuis-Emilio García-Pérez
May 20, 2020·Expert Opinion on Drug Safety·Rajesh Peter, Steve C Bain
Oct 21, 2019·Hormones : International Journal of Endocrinology and Metabolism·Paschou Sa, Theodoros Alexandrides
Feb 23, 2020·Liver International : Official Journal of the International Association for the Study of the Liver·Kenneth Cusi
Apr 30, 2019·Frontiers in Endocrinology·Lotte Bjerre Knudsen, Jesper Lau
Feb 23, 2021·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Matthias HepprichGottfried Rudofsky
Mar 24, 2021·JAMA : the Journal of the American Medical Association·Domenica RubinoUNKNOWN STEP 4 Investigators
Jul 22, 2021·Seminars in Liver Disease·Sabine KahlMichael Roden
Aug 19, 2021·The Journal of Clinical Endocrinology and Metabolism·Chandani Patel ChavezSushma Kadiyala

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