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Diabetes Care. 2018 Feb;41(2):258-266. doi: 10.2337/dc17-0417. Epub 2017 Dec 15.

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.

Author information

1
Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR ahmanna@ohsu.edu.
2
Rotherham Institute for Obesity, Clifton Medical Centre, Rotherham, U.K.
3
Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France.
4
Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy.
5
Center for Clinical Studies, GWT-TU Dresden, Dresden, Germany.
6
Departments of Internal Medicine and Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX.
7
Novo Nordisk A/S, Søborg, Denmark.
8
Novo Nordisk Inc., Plainsboro, NJ.
9
MedStar Health Research Institute, Hyattsville, MD.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01885208.

PMID:
29246950
DOI:
10.2337/dc17-0417
[Indexed for MEDLINE]

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