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The addition of liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, to metformin with or without basal insulin, improves glycemic control in children and adolescents with type 2 diabetes (T2D), according to the results of a recent study.
The ELLIPSE trial included 134 children and adolescents aged 10 to <17 years old with T2D. The patients were randomly assigned to receive up to 1.8mg of liraglutide daily (N=66) or placebo (N=68) in addition to metformin (+/- basal insulin). The study consisted of a 26-week double-blinded period followed by a 26-week open-label extension period. During the extension period, treatment remained unchanged for the liraglutide patients while placebo patients continued metformin (+/- basal insulin) only.
“Inclusion criteria were a body-mass index greater than the 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),” the study authors explained. The primary outcome of the study was glycated hemoglobin level change from baseline to week 26; safety was also evaluated throughout the study.
Baseline demographics were found to be similar between the treatment groups. The authors reported that after 26 weeks, patients who received liraglutide experienced a mean glycated hemoglobin level decrease of 0.64 percentage points while placebo patients experienced an increase of 0.42 percentage points, correlating to a treatment difference of -1.06 percentage points (P<.001). By 52 weeks, the treatment difference was found to increase to -1.30 percentage points.
As for the secondary endpoints, liraglutide was found to be superior to placebo in reducing fasting plasma glucose levels. In addition, more patients in the liraglutide group achieved glycated hemoglobin levels of <7.0% (63.7% vs 36.5% for placebo; P<.001).
Results of the study also showed adverse event rates were similar between the treatment groups, with 84.8% of liraglutide patients (N=56) reporting an adverse event vs 80.9% of placebo patients (N=55). However, the authors noted, the overall rates of adverse events and gastrointestinal adverse events were found to be higher in patients receiving liraglutide.
Data from the ELLIPSE trial have been submitted to the Food and Drug Administration by Novo Nordisk, the makers of Victoza (liraglutide injection), for evaluation as a potential treatment for children ≥10 years old with T2D. Victoza is currently approved as an adjunct to diet and exercise, to improve glycemic control in adults with T2D and to reduce the risk of major adverse cardiovascular (CV) events (eg, CV death, non-fatal MI/stroke) in adults with T2D and established CV disease.
For more information visit nejm.org.
