- In patients with type 2 diabetes (T2D) at high cardiovascular (CV) risk, adding liraglutide improved glycaemic control and reduced body weight and insulin need for ≤3 years without increasing hypoglycaemia.
Why this matters
- Previous studies of glucagon-like peptide-1 receptor agonists plus insulin were ≤1 year.
- LEADER assessed CV safety/efficacy of 1.8 mg liraglutide vs placebo (plus standard of care) in 9340 patients with T2D at high CV event risk; median follow-up, 3.8 years.
- Funding: Novo Nordisk A/S.
- Proportions with HbA1c reductions of >0.05 percentage points without weight gain with liraglutide vs placebo were 39.4% vs 20.2% (OR, 2.57; 95% CI, 2.17-3.03) for the 3159 on basal-only insulin and 34.0% vs 18.4% (2.58; 1.90-3.52) for 1010 on other insulin regimens.
- In basal-only group, severe hypoglycemia rates for liraglutide vs placebo were 1.2 vs 2.6 episodes/100 person-years (rate ratio, 0.44; 0.28-0.70); no difference in other insulin groups.
- Insulin requirements lower with liraglutide vs placebo, for initiation (30% vs 47%; HR, 0.55; 95% CI, 0.50-0.60), dose reduction, and discontinuation (10% vs 6%; 1.62; 1.16-2.27).
- Liraglutide group had greater reductions in body weight, systolic BP, and low-density lipoprotein cholesterol.
- Post-hoc analysis.
- Subgroup analysis based on baseline insulin use only.