1. In children with type 2 diabetes (T2DM) on metformin, those randomized to liraglutide had better glycemic control after 26 weeks compared to placebo treated patients.
2. Patients treated with liraglutide experienced more adverse events and gastrointestinal issues than placebo patients.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Incidence of both childhood obesity and T2DM are increasing. Metformin is standard treatment for youth with T2DM, though second-line therapies are lacking for children compared to adults with T2DM. The glucagon-like peptide-1 analog liraglutide has shown promise in a phase 2 study in children, and further confirmation of efficacy would add to the possible treatment options for young T2DM patients. The Evaluation of Liraglutide in Pediatrics with Diabetes (Ellipse) trial showed after 26 weeks of treatment, T2DM children on metformin randomized to receive liraglutide experienced better glycemic control than placebo treated patients. Liraglutide treated patients also experienced more overall adverse events and gastrointestinal issues.
This phase 3 study provides rationale for the use of liraglutide in children with T2DM already on metformin for additional glycemic control. Strengths of the study included the randomized design and in-depth adverse event reporting, while it is limited by the length of follow-up only out to 52 weeks and the relatively small number of patients.
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