PAS 2019—Liraglutide effective for pediatric T2D

  • Emily Willingham, PhD
  • Conference Reports
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  • 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.

Key results

  • 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.

Study design

  • 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.

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