PT  - JOURNAL ARTICLE
AU  - Garvey, W. Timothy
AU  - Birkenfeld, Andreas L.
AU  - Dicker, Dror
AU  - Mingrone, Geltrude
AU  - Pedersen, Sue D.
AU  - Satylganova, Altynai
AU  - Skovgaard, Dorthe
AU  - Sugimoto, Danny
AU  - Jensen, Camilla
AU  - Mosenzon, Ofri
TI  - Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial
AID  - 10.2337/dc19-1745
DP  - 2020 Mar 03
TA  - Diabetes Care
PG  - dc191745
4099  - http://care.diabetesjournals.org/content/early/2020/02/27/dc19-1745.short
4100  - http://care.diabetesjournals.org/content/early/2020/02/27/dc19-1745.full
AB  - OBJECTIVE Most individuals with type 2 diabetes also have obesity, and treatment with some diabetes medications, including insulin, can cause further weight gain. No approved chronic weight-management medications have been prospectively investigated in individuals with overweight or obesity and insulin-treated type 2 diabetes. The primary objective of this study was to assess the effect of liraglutide 3.0 mg versus placebo on weight loss in this population.RESEARCH DESIGN AND METHODS Satiety and Clinical Adiposity—Liraglutide Evidence (SCALE) Insulin was a 56-week, randomized, double-blind, placebo-controlled, multinational, multicenter trial in individuals with overweight or obesity and type 2 diabetes treated with basal insulin and less than or equal to two oral antidiabetic drugs.RESULTS Individuals were randomized to liraglutide 3.0 mg (n = 198) or placebo (n = 198), combined with intensive behavioral therapy (IBT). At 56 weeks, mean weight change was −5.8% for liraglutide 3.0 mg versus −1.5% with placebo (estimated treatment difference −4.3% [95% CI −5.5; −3.2]; P < 0.0001). With liraglutide 3.0 mg, 51.8% of individuals achieved ≥5% weight loss versus 24.0% with placebo (odds ratio 3.41 [95% CI 2.19; 5.31]; P < 0.0001). Liraglutide 3.0 mg was associated with significantly greater reductions in mean HbA1c, mean daytime glucose values, and less need for insulin versus placebo, despite a treat-to–glycemic target protocol. More hypoglycemic events were observed with placebo than liraglutide 3.0 mg. No new safety or tolerability issues were observed.CONCLUSIONS In individuals with overweight or obesity and insulin-treated type 2 diabetes, liraglutide 3.0 mg as an adjunct to IBT was superior to placebo regarding weight loss and improved glycemic control despite lower doses of basal insulin and without increases in hypoglycemic events.