Impact of Liraglutide on Weight Loss Among Diabetics
What is the efficacy and safety of liraglutide (vs. placebo) for weight management in adults with overweight or obesity and type 2 diabetes?
SCALE (Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes) was a multicenter, international, 56-week, randomized, double-blind, placebo-controlled trial. Eligible participants were overweight or obese adults with a stable body weight, glycated hemoglobin between 7.0% and 10.0%, and treatment with 1-3 oral hypoglycemic agents. Participants were randomized to one of three groups: liraglutide (3.0 mg), liraglutide (1.8 mg), or placebo. These interventions were adjunct to 500 kcal/day dietary deficit and increased physical activity (>150 minutes/week) for all participants. The following were three coprimary endpoints: relative change in body weight, proportion of participants losing ≥5% of baseline body weight, and proportion of patients losing >10% of baseline body weight.
Of 1,361 participants assessed for eligibility, 846 were randomized. 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. Weight loss of ≥5% 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% confidence interval (CI), 24.6%-41.2%]; for liraglutide [1.8 mg] vs. placebo, 19.0% [95% CI, 9.1%-28.8%]; p < 0.001 for both). Weight loss >10% occurred in 25.2% with liraglutide (3.0 mg) and 15.9% with liraglutide (1.8 mg) versus 6.7% with placebo (estimated difference for liraglutide [3.0 mg] vs. placebo, 18.5% [95% CI, 12.7%-24.4%], p < 0.001; for liraglutide [1.8 mg] vs. placebo, 9.3% [95% CI, 2.7%-15.8%], p = 0.006). Event rates for adverse events and adverse events leading to withdrawal were higher with liraglutide than placebo, mainly driven by a higher rate of gastrointestinal adverse events. No cases of acute pancreatitis were reported. Mean heart rate increases of 2.0/min and 2.1/min occurred with liraglutide (3.0 mg) and liraglutide (1.8 mg) vs. -1.4/min for placebo (p < 0.001 vs. placebo).
Compared with placebo, use of subcutaneous liraglutide (3.0 mg), as an adjunct to a reduced-calorie diet and increased physical activity, resulted in greater weight loss over 56 weeks.
While further studies are needed to evaluate longer-term efficacy and safety, the results of this analysis point toward the benefits of liraglutide on all weight- and glycemic-related endpoints. In particular, the higher dose of liraglutide (3.0 mg) was statistically significantly better than liraglutide 1.8 mg on all weight-related endpoints. The safety profile was similar between the doses. Further studies should clarify the significance of liraglutide’s impact on heart rate.
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