EASD 2019 — Liraglutide + metformin improves glucose control in children, adolescents with T2D

Study design

• Children and adolescents (age range, 10-17 [mean age, 14.6] years) with T2D and a BMI >85^th percentile were randomly assigned (1:1):
  • Liraglutide ≤1.8 mg/day or maximum tolerated dose (n=66). 
  • Placebo (n=68).
• Treatment commenced for a 26-week double-blind period followed by a 26-week open-label extension period.
• The primary endpoint included the change in HbA1c from baseline to 26 weeks.
• Funding: Novo Nordisk.

Key results

• Participants in the liraglutide group had reductions in HbA1c from 7.87% at baseline to 7.13% at 26 weeks vs increases in the placebo group from 7.69% to 8.19% (estimated treatment difference [ETD], −1.06%; 95% CI, −1.65 to −0.46; P<.001>
• At 52 weeks, liraglutide was also associated with reductions in HbA1c, whereas placebo was associated with increases in HbA1c (ETD, −1.30%; 95% CI, −1.89 to −0.70; P<.001>
• Adverse event (AE) rates were similar between the liraglutide (84.8%) and placebo (80.9%) groups.
• Liraglutide was associated with a higher rate of gastrointestinal AEs (33.3%) vs placebo (13.2%).

Limitations

• Long recruitment period.