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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.

MedStar author(s):

Citation: Diabetes Care. 41(2):258-266, 2018 02.PMID: 29246950Institution: MedStar Health Research InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Diabetes Mellitus, Type 2/dt [Drug Therapy] | *Glucagon-Like Peptides/ad [Administration & Dosage] | *Glucagon-Like Peptides/ae [Adverse Effects] | *Peptides/ad [Administration & Dosage] | *Peptides/ae [Adverse Effects] | *Venoms/ad [Administration & Dosage] | *Venoms/ae [Adverse Effects] | Adult | Aged | Aged, 80 and over | Blood Glucose/de [Drug Effects] | Blood Glucose/me [Metabolism] | Body Weight/de [Drug Effects] | Delayed-Action Preparations/ad [Administration & Dosage] | Delayed-Action Preparations/ae [Adverse Effects] | Diabetes Mellitus, Type 2/bl [Blood] | Drug Administration Schedule | Female | Glycated Hemoglobin A/de [Drug Effects] | Humans | Hypoglycemic Agents/ad [Administration & Dosage] | Hypoglycemic Agents/ae [Adverse Effects] | Male | Metformin/ad [Administration & Dosage] | Middle Aged | Treatment Outcome | Young AdultYear: 2018 Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006ISSN:

0149-5992

Name of journal: Diabetes careAbstract: 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 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%).All authors: Ahmann AJ, Annett MP, Aroda VR, Capehorn M, Charpentier G, Dotta F, Henkel E, Holst AG, Lingvay IFiscal year: FY2018Digital Object Identifier:

https://dx.doi.org/10.2337/dc17-0417

ORCID:

http://orcid.org/0000-0002-4544-5404 http://orcid.org/0000-0001-7006-7401 http://orcid.org/0000-0002-4544-5404 http://orcid.org/0000-0001-7006-7401
http://orcid.org/0000-0002-4544-5404 http://orcid.org/0000-0001-7006-7401 http://orcid.org/0000-0002-4544-5404 http://orcid.org/0000-0001-7006-7401

Date added to catalog: 2018-01-18

Holdings ( 1 )
Title notes ( 6 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	29246950	Available		29246950

Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006

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 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%).

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