- In children and adolescents with type 2 diabetes (T2D) who are considered overweight and have inadequately controlled glycemia, liraglutide plus metformin with or without insulin was superior to placebo for reducing HbA1c at up to 52 weeks.
Why this matters
- Metformin and insulin are the only currently approved agents for children and adolescents with T2D.
- Children and adolescents (age range, 10-17 [mean age, 14.6] years) with T2D and a BMI >85th 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.
- 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%).
- Long recruitment period.