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.
Bibliographical noteFunding Information:
C.T.B. was funded by the National Institutes of Health's National Center for Advancing Translational Sciences, grants KL2TR002492 and UL1TR002494. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health's National Center for Advancing Translational Sciences. T.V.S.D., P.M.H. and C.K.R. are full‐time employees of Novo Nordisk; CKR and PMH also hold shares in Novo Nordisk.
Parts of these analyses have been accepted as poster presentations at ECO‐ICO 2020 and EASD 2020. M.O.B. is the guarantor of the article, had full access to all data presented and takes responsibility for its integrity and analysis. Datasets for the research presented in this study are available from the corresponding author on request. The authors are grateful to Alice Singleton, MSc, and Izabel James, MBBS, of Watermeadow Medical, an Ashfield company, part of UDG Healthcare, for medical writing and editing support, funded by Novo Nordisk A/S.
© 2021 World Obesity Federation
- anti-obesity agents
- body mass index
- paediatric obesity