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. 

 -  2018 
<br/><br/>Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006 
<br/><br/> 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.  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 HbA<sub>1c</sub> at week 56.  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%). 
<br/><br/><br/>English 
<br/><br/><label>ISSN: </label>0149-5992 
<br/><br/><label>Standard No.: </label>10.2337/dc17-0417 [doi] dc17-0417 [pii] 
<br/><br/><label>Subjects--Topical Terms: </label><br/>*Diabetes Mellitus, Type 2/dt [Drug Therapy]<br/>*Glucagon-Like Peptides/ad [Administration & Dosage]<br/>*Glucagon-Like Peptides/ae [Adverse Effects]<br/>*Peptides/ad [Administration & Dosage]<br/>*Peptides/ae [Adverse Effects]<br/>*Venoms/ad [Administration & Dosage]<br/>*Venoms/ae [Adverse Effects]<br/>Adult<br/>Aged<br/>Aged, 80 and over<br/>Blood Glucose/de [Drug Effects]<br/>Blood Glucose/me [Metabolism]<br/>Body Weight/de [Drug Effects]<br/>Delayed-Action Preparations/ad [Administration & Dosage]<br/>Delayed-Action Preparations/ae [Adverse Effects]<br/>Diabetes Mellitus, Type 2/bl [Blood]<br/>Drug Administration Schedule<br/>Female<br/>Glycated Hemoglobin A/de [Drug Effects]<br/>Humans<br/>Hypoglycemic Agents/ad [Administration & Dosage]<br/>Hypoglycemic Agents/ae [Adverse Effects]<br/>Male<br/>Metformin/ad [Administration & Dosage]<br/>Middle Aged<br/>Treatment Outcome<br/>Young Adult
<br/><br/><label>Subjects--Geographic Terms: </label><br/>MedStar Health Research Institute
<br/><br/><label>Index Terms--Function: </label><br/>Journal Article