Effect of liraglutide treatment on body mass index and weight parameters in children and adolescents with type 2 diabetes: Post hoc analysis of the ellipse trial.

Bensignor MO, Bomberg EM, Bramante CT, Divyalasya TVS, Hale PM, Ramesh CK, Rudser KD, Kelly AS

Pediatric obesity25 Feb 2021Cited by 22 (Europe PMC)

PMID33634589PMCIDPMC8277686DOI10.1111/ijpo.12778PepBankPUB-33634589

Summary

BackgroundWeight loss in children and adolescents with type 2 diabetes (T2D) is associated with improved glycaemic control.ObjectivesTo 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).MethodsThe ellipse trial randomized participants (10-85th percentile, T2D, glycated haemoglobin [HbA_1c ] 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.ResultsIn 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.ConclusionsCompared 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.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In children and adolescents with type 2 diabetes, liraglutide lowered absolute BMI more than placebo at week 52 (estimated treatment difference -0.89 kg/m2).
In plain wordsIn children and adolescents with type 2 diabetes, liraglutide lowered body mass index more than placebo after 52 weeks.
Peptide
Liraglutide
Outcome
DecreaseAbsolute BMI at week 52
Study
n = 134
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
0.6, 1.2 and 1.8 mg/dayAs given in this study (human).
Measurements
estimated treatment difference in BMI
−0.89 kg/m<sup>2</sup>
week 52
Source sentences
Summary
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.
1 context sentence(design, population, supporting numbers)
Summary · context
The ellipse trial randomized participants (10-85th percentile, T2D, glycated haemoglobin [HbA_1c ] 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.
Show in the study text Report a problemFND-3363458901
02HumanRandomized controlled trialEfficacy outcome
In children and adolescents with type 2 diabetes, liraglutide lowered the percent change in BMI more than placebo at week 52 (estimated treatment difference -2.73%).
In plain wordsIn children and adolescents with type 2 diabetes, liraglutide lowered body mass index by a larger percentage than placebo after 52 weeks.
Peptide
Liraglutide
Outcome
DecreasePercent change in BMI at week 52
Study
n = 134
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
0.6, 1.2 and 1.8 mg/dayAs given in this study (human).
Measurements
estimated treatment difference in percent BMI change
−2.73%
week 52
Source sentences
Summary
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.
1 context sentence(design, population, supporting numbers)
Summary · context
The ellipse trial randomized participants (10-85th percentile, T2D, glycated haemoglobin [HbA_1c ] 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.
Show in the study text Report a problemFND-3363458902
03HumanRandomized controlled trialEfficacy outcome
In children and adolescents with type 2 diabetes, liraglutide did not differ significantly from placebo in BMI and weight parameters at week 26.
In plain wordsIn children and adolescents with type 2 diabetes, liraglutide did not change body mass index more than placebo after 26 weeks.
Peptide
Liraglutide
Outcome
No significant changeBMI and weight parameters at week 26
Study
n = 134
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
0.6, 1.2 and 1.8 mg/dayAs given in this study (human).
Source sentences
Summary
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.
1 context sentence(design, population, supporting numbers)
Summary · context
The ellipse trial randomized participants (10-85th percentile, T2D, glycated haemoglobin [HbA_1c ] 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.
Show in the study text Report a problemFND-3363458903
04HumanRandomized controlled trialEfficacy outcome
In children and adolescents with type 2 diabetes, dose-dependent effects of liraglutide versus placebo were not observed for BMI and weight parameters.
In plain wordsIn children and adolescents with type 2 diabetes, higher liraglutide doses did not give a larger drop in body mass index than lower doses.
Peptide
Liraglutide
Outcome
No significant changeDose-dependent effect on BMI and weight parameters
Study
n = 134
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
0.6, 1.2 and 1.8 mg/dayAs given in this study (human).
Source sentences
Summary
Dose-dependent effects were not observed for liraglutide vs placebo for all BMI/weight parameters.
1 context sentence(design, population, supporting numbers)
Summary · context
The ellipse trial randomized participants (10-85th percentile, T2D, glycated haemoglobin [HbA_1c ] 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.
Show in the study text Report a problemFND-3363458904

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01541215

Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes

Novo Nordisk A/Sn = 13513 Nov 2012 to 20 May 2020

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 2 Jul 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
12 Oct 2026, 11:11 UTC
Study results updated
Version 1
9 Oct 2026, 03:05 UTC
First added · source update from Europe PMC

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