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Liraglutide in Youth With Type 2 Diabetes
Study Questions:
Is liraglutide, when added to metformin, safe and effective in youth with type 2 diabetes mellitus?
Methods:
The Ellipse (Evaluation of Liraglutide in Pediatrics With Diabetes) study was a randomized controlled trial, which enrolled participants who were age 10 to <17 years of age to either subcutaneous liraglutide (up to 1.8 mg per day) or placebo for a 26-week double-blind period, followed by a 26-week open-label extension period. Children were eligible if they had a body mass index >85th percentile and a glycated hemoglobin level between 7.0 and 11.0% (if the patients were being treated with diet and exercise alone) or between 6.5 and 11.0% (if they were being treated with metformin [with or without insulin]). All the patients received metformin during the trial. The primary endpoint was the change from baseline in the glycated hemoglobin level after 26 weeks. Secondary endpoints included the change in fasting plasma glucose level. Safety was assessed throughout the trial.
Results:
A total of 135 patients (mean age 14.6 years, 61.9% female) underwent randomization, and 134 received at least one dose of liraglutide (66 patients) or placebo (68 patients). At the 26-week analysis of the primary efficacy endpoint, the mean glycated hemoglobin level had decreased by 0.64 percentage points with liraglutide and increased by 0.42 percentage points with placebo, for an estimated treatment difference of −1.06 percentage points (p < 0.001); the difference increased to −1.30 percentage points by 52 weeks. Fasting plasma glucose levels increased in the placebo group and decreased in the liraglutide group. Reported adverse events were similar between the two groups (56 [84.8%] with liraglutide and 55 [80.9%] with placebo), but the overall rates of adverse events and gastrointestinal adverse events were higher with liraglutide.
Conclusions:
The investigators concluded that in children and adolescents with type 2 diabetes, liraglutide, at a dose of up to 1.8 mg per day (added to metformin, with or without basal insulin) was efficacious in improving glycemic control over 52 weeks. This efficacy came at the cost of an increased frequency of gastrointestinal adverse events.
Perspective:
These data suggest that liraglutide may be effective for youth with type 2 diabetes when used in conjunction with metformin. Further study including in populations outside Europe and North American will provide additional information on the generalizability of using liraglutide in this population.
Clinical Topics: Cardiovascular Care Team, Congenital Heart Disease and Pediatric Cardiology, Diabetes and Cardiometabolic Disease, Prevention, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Prevention, Diet, Exercise
Keywords: Adolescent, Blood Glucose, Body Mass Index, Child, Diabetes Mellitus, Type 2, Diet, Exercise, Fasting, Hemoglobin A, Insulin, Metabolic Syndrome, Metformin, Pediatrics, Primary Prevention
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