MedStar Authors catalog › Details for: 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.
Citation: Diabetes Care. , 2017 Dec 15.Journal: Diabetes care.Published: 2017ISSN: 0149-5992.Full author list: Ahmann AJ; Capehorn M; Charpentier G; Dotta F; Henkel E; Lingvay I; Holst AG; Annett MP; Aroda VR.UI/PMID: 29246950.Subject(s): IN PROCESS -- NOT YET INDEXEDInstitution(s): MedStar Health Research InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleDigital Object Identifier: https://dx.doi.org/10.2337/dc17-0417 (Click here)ORCID: Ahmann, Andrew J http://orcid.org/0000-0002-4544-5404Lingvay, Ildiko http://orcid.org/0000-0001-7006-7401 (Click here) | (Click here)Abbreviated citation: Diabetes Care. , 2017 Dec 15.Local Holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006.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.Abstract: 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 HbA<sub>1c</sub> at week 56.Abstract: RESULTS: Mean HbA<sub>1c</sub> (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 HbA<sub>1c</sub> <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%).Abstract: 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. Copyright (c) 2017 by the American Diabetes Association.