Efficacy of liraglutide for weight loss among patients with type 2 diabetes: The SCALE diabetes randomized clinical trial

NN8022-1922 Study Group

Research output: Contribution to journalArticle

300 Scopus citations

Abstract

Importance: 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 (3.0mg) (n = 423), liraglutide (1.8mg) (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 inweight, proportion of participants losing 5% or more, or more than 10%, of baselineweight atweek 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 [3.0mg] vs placebo, -4.00% [95% CI, -5.10% to -2.90%]; liraglutide [1.8mg] 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 (3.0mg) and 40.4% with liraglutide (1.8mg) vs 21.4% with placebo (estimated difference for liraglutide [3.0mg] vs placebo, 32.9% [95% CI, 24.6% to 41.2%]; for liraglutide [1.8mg] 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 (3.0mg) and 15.9% with liraglutide (1.8mg) vs 6.7% with placebo (estimated difference for liraglutide [3.0mg] vs placebo, 18.5% [95% CI, 12.7% to 24.4%], P < .001; for liraglutide [1.8mg] vs placebo, 9.3% [95% CI, 2.7% to 15.8%], P = .006). More gastrointestinal disorders were reported with liraglutide (3.0mg) vs liraglutide (1.8mg) and placebo. No pancreatitis was reported. Conclusions and Relevance: Among overweight and obese participants with type 2 diabetes, use of subcutaneous liraglutide (3.0mg) daily, compared with placebo, resulted inweight loss over 56weeks. Further studies are needed to evaluate longer-term efficacy and safety.

Original languageEnglish (US)
Pages (from-to)687-699
Number of pages13
JournalJAMA - Journal of the American Medical Association
Volume314
Issue number7
DOIs
StatePublished - Aug 18 2015

ASJC Scopus subject areas

  • Medicine(all)

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