Weight loss with liraglutide 3.0 mg is associated with improved health-related quality of life (HRQoL) and treatment satisfaction in overweight or obese adults with type 2 diabetes (T2D): The SCALE Diabetes randomised, double-blind, placebo-controlled 56-week trial (#304)
Obesity is a chronic disease associated with type 2 diabetes (T2D) and impaired health-related quality of life (HRQoL), which can be improved by a 5–10% weight loss. We studied the impact of weight loss with liraglutide 3.0 mg, as an adjunct to diet and exercise, compared with placebo and liraglutide 1.8 mg on HRQoL in overweight/obese adults with T2D.
846 participants (means: age 55 years; males 50%; BMI 37 (27–68) kg/m2; HbA1c 7.9%; diabetes duration 7.3 (0.2–36) years; 11% on diet + exercise, 57% on metformin monotherapy, 31% on combination oral antidiabetics) were randomised (2:1:1) to 56 weeks of once-daily subcutaneous liraglutide 3.0 mg (n=423), 1.8 mg (n=211) or placebo (n=212) treatment + guided diet (500 kcal/day deficit) and exercise. The Impact of Weight on Quality of Life (IWQoL) Lite and Diabetes Treatment Satisfaction Questionnaire (DTSQ) were used to assess health-related outcomes at baseline, 28 weeks, and 56 weeks. Clinicaltrials.gov ID: NCT01272232. Funding: Novo Nordisk.
At week 56, weight loss (mean±SD) from baseline with liraglutide 3.0 mg was 5.9±5.5% compared with 4.6±5.5% (p=0.0024) with liraglutide 1.8 mg and 2.0±4.3% (p<0.0001) with placebo. The mean total score of the IWQoL-Lite improved with 3.0 mg (11.7±14.7), but not with 1.8 mg (9.1±14.1), vs. placebo (7.6±12.6; estimated difference (ED) and [95% CI]: 2.8 [0.6–4.9]; p=0.014); this was driven by an improved physical function score (15.2±18.0 with 3.0 mg vs. 9.5±16.6 with placebo; ED: 4.9 [2.1–7.7]; p=0.0006). Liraglutide 3.0 mg, but not 1.8 mg, also improved the DTSQ vs. placebo (ED: 1.4 [0.4–2.5]; p<0.01).
In overweight/obese individuals with T2D, liraglutide 3.0 mg, as adjunct to diet and exercise, was superior to placebo and 1.8 mg on weight loss, and also significantly improved HRQoL and diabetes treatment satisfaction.