Background: This 3-year trial investigated the effect of liraglutide 3.0 mg, as an adjunct to diet+exercise, in delaying onset of T2D (primary endpoint) in adults with prediabetes and obesity (BMI ≥30 kg/m²) or overweight (≥27 kg/m²) with comorbidities.
Methods: Participants were randomised 2:1 to once-daily subcutaneous liraglutide 3.0 mg or placebo plus 500 kcal/day deficit diet and 150 min/week exercise. Efficacy data are observed means, with last observation carried forward for missing values. Clinicaltrials.gov ID: NCT01272219.
Results: Of 2254 randomised individuals with prediabetes (age 47.5±11.7 years, 76.0% female, weight 107.6±21.6 kg, BMI 38.8±6.4 kg/m², mean±SD), 1128 completed 160 weeks (52.6% on liraglutide, 45.0% on placebo). At Week 160, mean weight loss (WL) was 6.1% with liraglutide vs. 1.9% with placebo (estimated treatment difference ‑4.3% [95%CI -4.9;-3.7], p<0.0001). Comparing liraglutide and placebo, 49.6% vs 23.7% of individuals achieved ≥5% WL (estimated odds ratio [OR] 3.2 [2.6;3.9]) and 24.8% vs 9.9% achieved >10% WL (OR 3.1 [2.3;4.1]), both pp<0.001; hazard ratio: 0.2). Liraglutide was generally well tolerated. Gallbladder-related events (2.9 vs 1.2/100 patient-years of observation [PYO]) and confirmed pancreatitis (0.29 vs 0.13 events/100 PYO) were low, but more frequent with liraglutide.
Conclusion: Liraglutide 3.0 mg, plus diet+exercise over 3 years was associated with greater weight loss and reduced risk of T2D compared to placebo.
Supported by Novo Nordisk.