- In pediatric type 2 diabetes (T2D), liraglutide added to metformin improves glycemic control to 1 year.
- Increased gastrointestinal adverse events seen with liraglutide in this phase 3 trial (Evaluation of Liraglutide in Pediatrics with Diabetes; Ellipse) with no BMI differences vs placebo.
Why this matters
- Metformin monotherapy is linked to early reductions in glycemic control with pediatric use.
- The addition of liraglutide could yield a more robust benefit.
- At 26 weeks, mean HbA1c decreased 0.64 percentage points with liraglutide.
- It increased 0.42 percentage points with placebo.
- Treatment difference: −1.06 percentage points (0.50 decrease with liraglutide vs 0.80 increase with placebo; P<.001>
- By 52 weeks, that difference had widened to −1.30 percentage points, favoring liraglutide.
- Almost twice as many in liraglutide group vs placebo achieved HbA1c
- Adverse event rates were similar (84.8% with liraglutide vs 80.9% placebo), but gastrointestinal events specifically were more frequent with liraglutide.
- Randomized, double-blind, placebo-controlled trial, children ages 10 to
- A 26-week open-label extension period followed.
- Included children had HbA1c 7.0%-11.0% with lifestyle intervention only or 6.5%-11.0% metformin treated with/without insulin.
- All children were on metformin during the trial.
- Funding: Novo Nordisk.
- Potentially too rapid dose escalation.
- Long recruitment period led to protocol amendments.
- Generalizability from low-diversity population unclear.