Please use this identifier to cite or link to this item: http://hdl.handle.net/2381/36026
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dc.contributor.authorDavies, Melanie J.-
dc.contributor.authorBergenstal, R.-
dc.contributor.authorBode, B.-
dc.contributor.authorKushner, R. F.-
dc.contributor.authorLewin, A.-
dc.contributor.authorSkjøth, T. V.-
dc.contributor.authorAndreasen, A. H.-
dc.contributor.authorJensen, C. B.-
dc.contributor.authorDeFronzo, R. A.-
dc.contributor.authorNN8022-1922 Study Group-
dc.date.accessioned2015-12-08T15:28:44Z-
dc.date.available2016-02-18T02:45:08Z-
dc.date.issued2015-08-18-
dc.identifier.citationJAMA, 2015, 314 (7), pp. 687-699en
dc.identifier.issn0098-7484-
dc.identifier.urihttp://jama.jamanetwork.com/article.aspx?articleid=2428956en
dc.identifier.urihttp://hdl.handle.net/2381/36026-
dc.description.abstractIMPORTANCE: Weight loss of 5% to 10% can improve type 2 diabetes and related comorbidities. Few safe, effective weight-management drugs are currently available. OBJECTIVE: To investigate efficacy and safety of liraglutide vs placebo for weight management in adults with overweight or obesity and type 2 diabetes. DESIGN, SETTING, AND PARTICIPANTS: Fifty-six-week randomized (2:1:1), double-blind, placebo-controlled, parallel-group trial with 12-week observational off-drug follow-up period. The study was conducted at 126 sites in 9 countries between June 2011 and January 2013. Of 1361 participants assessed for eligibility, 846 were randomized. Inclusion criteria were body mass index of 27.0 or greater, age 18 years or older, taking 0 to 3 oral hypoglycemic agents (metformin, thiazolidinedione, sulfonylurea) with stable body weight, and glycated hemoglobin level 7.0% to 10.0%. INTERVENTIONS: Once-daily, subcutaneous liraglutide (3.0 mg) (n = 423), liraglutide (1.8 mg) (n = 211), or placebo (n = 212), all as adjunct to 500 kcal/d dietary deficit and increased physical activity (≥150 min/wk). MAIN OUTCOMES AND MEASURES: Three coprimary end points: relative change in weight, proportion of participants losing 5% or more, or more than 10%, of baseline weight at week 56. RESULTS: Baseline weight was 105.7 kg with liraglutide (3.0-mg dose), 105.8 kg with liraglutide (1.8-mg dose), and 106.5 kg with placebo. Weight loss was 6.0% (6.4 kg) with liraglutide (3.0-mg dose), 4.7% (5.0 kg) with liraglutide (1.8-mg dose), and 2.0% (2.2 kg) with placebo (estimated difference for liraglutide [3.0 mg] vs placebo, -4.00% [95% CI, -5.10% to -2.90%]; liraglutide [1.8 mg] vs placebo, -2.71% [95% CI, -4.00% to -1.42%]; P < .001 for both). Weight loss of 5% or greater occurred in 54.3% with liraglutide (3.0 mg) and 40.4% with liraglutide (1.8 mg) vs 21.4% with placebo (estimated difference for liraglutide [3.0 mg] vs placebo, 32.9% [95% CI, 24.6% to 41.2%]; for liraglutide [1.8 mg] vs placebo, 19.0% [95% CI, 9.1% to 28.8%]; P < .001 for both). Weight loss greater than 10% occurred in 25.2% with liraglutide (3.0 mg) and 15.9% with liraglutide (1.8 mg) vs 6.7% with placebo (estimated difference for liraglutide [3.0 mg] vs placebo, 18.5% [95% CI, 12.7% to 24.4%], P < .001; for liraglutide [1.8 mg] vs placebo, 9.3% [95% CI, 2.7% to 15.8%], P = .006). More gastrointestinal disorders were reported with liraglutide (3.0 mg) vs liraglutide (1.8 mg) and placebo. No pancreatitis was reported. CONCLUSIONS AND RELEVANCE: Among overweight and obese participants with type 2 diabetes, use of subcutaneous liraglutide (3.0 mg) daily, compared with placebo, resulted in weight loss over 56 weeks. Further studies are needed to evaluate longer-term efficacy and safety. TRIAL REGISTRATION: clinicaltrials.gov Identifier:NCT01272232.en
dc.description.sponsorshipThis study was funded by Novo Nordisk. Liraglutide is a Novo Nordisk A/S proprietary compound.en
dc.language.isoenen
dc.publisherAmerican Medical Association (AMA): JAMAen
dc.relation.urihttp://www.ncbi.nlm.nih.gov/pubmed/26284720-
dc.rightsArchived with reference to SHERPA/RoMEO and publisher website.en
dc.subjectAdulten
dc.subjectAgeden
dc.subjectBody Weighten
dc.subjectDiabetes Mellitus, Type 2en
dc.subjectDiet, Reducingen
dc.subjectDouble-Blind Methoden
dc.subjectExerciseen
dc.subjectFemaleen
dc.subjectGlucagon-Like Peptide 1en
dc.subjectHumansen
dc.subjectHypoglycemic Agentsen
dc.subjectInjections, Subcutaneousen
dc.subjectMaleen
dc.subjectMiddle Ageden
dc.subjectObesityen
dc.subjectWeight Lossen
dc.titleEfficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes: The SCALE Diabetes Randomized Clinical Trialen
dc.typeJournal Articleen
dc.identifier.doi10.1001/jama.2015.9676-
dc.identifier.eissn1538-3598-
dc.identifier.pii2428956-
dc.description.statusPeer-revieweden
dc.description.versionPublisher Versionen
dc.type.subtypeJournal Article;Multicenter Study;Randomized Controlled Trial;Research Support, Non-U.S. Gov't-
pubs.organisational-group/Organisationen
pubs.organisational-group/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGYen
pubs.organisational-group/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/School of Medicineen
pubs.organisational-group/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/School of Medicine/Department of Cardiovascular Sciencesen
pubs.organisational-group/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/Themesen
pubs.organisational-group/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/Themes/Cardiovascularen
pubs.organisational-group/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/Themes/Populationen
Appears in Collections:Published Articles, Dept. of Cardiovascular Sciences

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