RESUMEN
BACKGROUND: Weight loss in children and adolescents with type 2 diabetes (T2D) is associated with improved glycaemic control. OBJECTIVES: To assess the effects of liraglutide vs placebo on body mass index (BMI) and weight parameters in children and adolescents with T2D using data from the ellipse trial (NCT01541215). METHODS: The ellipse trial randomized participants (10-<17 years old, BMI >85th percentile, T2D, glycated haemoglobin [HbA1c ] 7.0%-11.0% [if diet- and exercise-treated] or 6.5% to 11.0% [if treated with metformin, basal insulin or both]) to liraglutide or placebo. This post-hoc analysis evaluated changes from baseline to weeks 26 and 52 in absolute BMI, percent change in BMI and other weight-related parameters. Changes were assessed by liraglutide overall (all doses) and liraglutide by dose (0.6, 1.2 and 1.8 mg/day) vs placebo using a pattern mixture model of observed data, with missing observations imputed from each treatment group. RESULTS: In total, 134 participants were included. There were statistically significant differences between groups in certain parameters, including absolute BMI (estimated treatment difference [ETD] -0.89 kg/m2 ; 95% confidence interval [CI] -1.71,-0.06) and percent change in BMI (ETD -2.73%; 95% CI -5.15,-0.30) at week 52, but none at week 26. Dose-dependent effects were not observed for liraglutide vs placebo for all BMI/weight parameters. CONCLUSIONS: Compared with placebo, liraglutide was associated with statistically significant reductions in BMI/weight parameters at week 52, but not week 26, in children and adolescents with T2D.