@article{24540ac01c3849a7bea5beb549292844,
title = "Efficacy and safety of once-Weekly semaglutide versus exenatide ER in subjects with type 2 diabetes (SUSTAIN 3): A 56-Week, open-Label, randomized clinical trial",
abstract = "OBJECTIVE To compare the efficacy and safety of once-weekly semaglutide 1.0 mg s.c. with exenatide extended release (ER) 2.0 mg s.c. in subjects with type 2 diabetes. RESEARCH DESIGN AND METHODS In this phase 3a, open-label, parallel-group, randomized controlled trial, 813 subjects with type 2 diabetes taking oral antidiabetic drugs were randomized (1:1) to semaglutide 1.0 mg or exenatide ER 2.0 mg for 56 weeks. The primary end point was change from baseline in HbA1c at week 56. RESULTS Mean HbA1c (8.3% [67.7 mmol/mol] at baseline) was reduced by 1.5% (16.8 mmol/mol) with semaglutide and 0.9% (10.0 mmol/mol) with exenatide ER (estimated treatment difference vs. exenatide ER [ETD] –0.62% [95% CI –0.80, –0.44] [–6.78 mmol/mol (95% CI –8.70, –4.86)]; P < 0.0001 for noninferiority and superiority). Mean body weight (95.8 kg at baseline) was reduced by 5.6 kg with semaglutide and 1.9 kg with exenatide ER (ETD –3.78 kg [95% CI –4.58, –2.98]; P < 0.0001). Significantly more subjects treated with semaglutide (67%) achieved HbA1c <7.0% (<53 mmol/mol) versus those taking exenatide ER (40%). Both treatments had similar safety profiles, but gastrointestinal adverse events were more common in semaglutide-treated subjects (41.8%) than in exenatide ER–treated subjects (33.3%); injection-site reactions were more frequent with exenatide ER (22.0%) than with semaglutide (1.2%). CONCLUSIONS Semaglutide 1.0 mg was superior to exenatide ER 2.0 mg in improving glycemic control and reducing body weight after 56 weeks of treatment; the drugs had comparable safety profiles. These results indicate that semaglutide treatment is highly effective for subjects with type 2 diabetes who are inadequately controlled on oral antidiabetic drugs.",
author = "Ahmann, {Andrew J.} and Matthew Capehorn and Guillaume Charpentier and Francesco Dotta and Elena Henkel and Ildiko Lingvay and Holst, {Anders G.} and Annett, {Miriam P.} and Aroda, {Vanita R.}",
note = "Funding Information: The funder contributed to the design and conduct of the study, the analysis and interpretation of the data, and the preparation, review, and approval of the manuscript. Duality of Interest. A.J.A. has received research support from Dexcom, Lexicon, Medtronic, Novo Nordisk, and Sanofi; travel support from Novo Nordisk; and consultancy fees from Dexcom and Novo Nordisk. M.C. has received honoraria and travel support from the Boehringer Ingelheim and Lilly Diabetes Alliance, Merck Sharpe & Dohme (MSD), and Novo Nordisk, and fees for service on advisory boards from the Boehringer Ingelheim and Lilly Diabetes Alliance, MSD, and Novo Nordisk; the Rotherham Institute for Obesity, with which M.C. is affiliated, has received research funds from Abbott, the Boehringer In-gelheim and Lilly Diabetes Alliance, Cambridge Weight Plan, LighterLife, Novartis, and Novo Nordisk. M.C. is an employee of LighterLife. G.C. has received honoraria for advisory panel/board membership from Becton Dickinson, Sanofi, Lilly, AstraZeneca, Novo Nordisk, and Boehringer Ingelheim, and speaker{\textquoteright}s bureau fees from Lilly. F.D. has received congress registration funding and travel support from Novo Nordisk; fees for service on advisory boards from Eli Lilly, LifeScan (a division of Cilag GmbH International), and Novo Nordisk; and lecture fees from Eli Lilly. I.L. has received grant support from GI Dynamics, Merck, Novartis, Novo Nordisk, and Pfizer; travel and accommodation support from AstraZeneca and Novo Nordisk; writing assistance, medicines, equipment, and administrative support from Novo Nordisk; consulting fees from AstraZeneca and Novo Nordisk; and payments for manuscript preparation from AstraZeneca, Boehringer Ingelheim, Novo Nordisk, and Pfizer. A.G.H. is an employee of Novo Nordisk A/S. M.P.A. is an employee of Novo Nordisk Inc. V.R.A. has received grant support from MedStar Health Research Institute, AstraZeneca, Bristol-Myers Squibb, Calibra, Eisai, Elcelyx, Janssen, Novo Nordisk, Sanofi, and Theracos; consulting fees from Adocia, the American Diabetes Association, AstraZeneca, Janssen, Medscape, MedStar Health Research Institute, Novo Nordisk, Sanofi, and Tufts University; and travel support from MedStar Health Research Institute. No other conflicts of interest relevant to this article were reported. Author Contributions. A.J.A., A.G.H., and M.P.A. conceivedanddesignedthestudy.M.P.A.performed statistical analysis. All authors acquired, analyzed, or interpreted data; drafted and critically revised the manuscript; and supervised the study. A.J.A. is the guarantorofthis workand,as such,had fullaccess to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Prior Presentation. The results of this study were presented at the 76th Scientific Sessions of the American Diabetes Association, New Orleans, LA, 10–14 June 2016; and at the 52nd annual meeting of the European Association for the Study of Diabetes, Munich, Germany, 12–16 September 2016. Publisher Copyright: {\textcopyright} 2017 by the American Diabetes Association.",
year = "2018",
month = feb,
day = "1",
doi = "10.2337/dc17-0417",
language = "English (US)",
volume = "41",
pages = "258--266",
journal = "Diabetes care",
issn = "0149-5992",
publisher = "American Diabetes Association Inc.",
number = "2",
}