@article{4bb39549b6e74b7baaf0b8fef735f8c9,
title = "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",
abstract = "OBJECTIVE: To 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 METHODS: 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. RESULTS: In total, 705 randomized patients were exposed to trial products. At week 26, a dose-dependent change in HbA1c was observed with semaglutide from 21.1% (0.05 mg) to 21.9% (0.3 mg) and with liraglutide from 20.5% (0.3 mg) to 21.3% (1.8 mg) (all P < 0.001 in favor of volume-matched semaglutide dose). Change with pooled placebo was 20.02% (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. CONCLUSIONS: Once-daily semaglutide at doses up to 0.3 mg/day resulted in greater reductions in HbA1c compared with liraglutide or placebo but with a higher frequency of GI AEs.",
author = "Ildiko Lingvay and Desouza, {Cyrus V.} and Lalic, {Katarina S.} and Ludger Rose and Thomas Hansen and Jeppe Zacho and Pieber, {Thomas R.}",
note = "Funding Information: Acknowledgments. The authors thank all the participants, investigators, and trial site staff who were involved in the conduct of the trial. The authors also thank Gurudutt Nayak (Novo Nordisk) for review of and input into the manuscript and Saroshi Amirthalingam and Sola Neunie (both AXON Communications, London, U.K.) for medical writing and editorial assistance, who received compensation from Novo Nordisk. Duality of Interest. This trial was funded by Novo Nordisk. I.L. has received research grants from Novo Nordisk, Merck, Pfizer, GI Dynamics, Novartis; consulting fees from Novo Nordisk, Lilly, Sanofi, and AstraZeneca; and other services (travel/editorial support) from Sanofi, Boehringer Ingelheim, AstraZeneca, and Novo Nordisk. C.V.D. has a consulting agreement with Novo Nordisk and has received research support from Janssen and Theracos. T.H. is an employee of Novo Nordisk. J.Z. is an employee and stock owner of Novo Nordisk. T.R.P. has received research grants from AstraZeneca and Novo Nordisk; has received consulting fees from Adocia, Astra-Zeneca, Eli Lilly, Novo Nordisk, and Roche Diabetes Care; and is Chief Scientific Officer of CBmed (Center for Biomarker Research in Medicine), a public-owned research company. No other potential conflicts of interest relevant to this article were reported. Author Contributions. I.L., T.H., J.Z., and T.R.P. researched data, reviewed and edited the manuscript, and contributed to the discussion. C.V.D. reviewed and edited the manuscript and contributed to the discussion. K.S.L. researched data and reviewed and edited the manuscript. L.R. researched data and reviewed and edited the manuscript. T.R.P. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.",
year = "2018",
month = sep,
day = "1",
doi = "10.2337/dc17-2381",
language = "English (US)",
volume = "41",
pages = "1926--1937",
journal = "Diabetes Care",
issn = "1935-5548",
publisher = "American Diabetes Association Inc.",
number = "9",
}