Liraglutide in Children and Adolescents with Type 2 Diabetes.

Tamborlane WV, Barrientos-Pérez M, Fainberg U, Frimer-Larsen H, Hafez M, Hale PM, Jalaludin MY, Kovarenko M, Libman I, Lynch JL, Rao P, Shehadeh N, Turan S, Weghuber D, Barrett T

The New England journal of medicine28 Apr 2019Cited by 272 (Europe PMC)

PMID31034184DOI10.1056/nejmoa1903822PepBankPUB-31034184

Publisher page PubMedAsk about this study

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In youth with type 2 diabetes taking metformin, liraglutide lowered HbA1c more than placebo at 26 weeks.
In plain wordsIn children and teenagers with type 2 diabetes on metformin, liraglutide lowered HbA1c more than placebo after 26 weeks.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change from baseline at 26 weeks
Study
n = 134
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
up to 1.8 mg per day · subcutaneous · 26 weeksAs given in this study (human).
Measurements
HbA1c change
−0.64 percentage points
liraglutide
HbA1c change
0.42 percentage points
placebo
Estimated treatment difference
−1.06 percentage points
26 weeks
Source sentences
Summary
At the 26-week analysis of the primary efficacy end point, the mean glycated hemoglobin level had decreased by 0.64 percentage points with liraglutide and increased by 0.42 percentage points with placebo, for an estimated treatment difference of -1.06 percentage points (P<0.001)
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who were 10 to less than 17 years of age were randomly assigned, in a 1:1 ratio, to receive subcutaneous liraglutide (up to 1.8 mg per day) or placebo for a 26-week double-blind period, followed by a 26-week open-label extension period.
Summary · context
All the patients received metformin during the trial.
Report a problemFND-3103418401
02HumanRandomized controlled trialEfficacy outcome
In youth with type 2 diabetes taking metformin, fasting plasma glucose decreased with liraglutide and increased with placebo at both time points.
In plain wordsIn children and teenagers with type 2 diabetes on metformin, fasting blood sugar fell with liraglutide and rose with placebo.
Peptide
Liraglutide
Outcome
DecreaseFasting plasma glucose change
Study
n = 134
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
up to 1.8 mg per day · subcutaneous · 26 to 52 weeksAs given in this study (human).
Source sentences
Summary
The fasting plasma glucose level had decreased at both time points in the liraglutide group but had increased in the placebo group.
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary end points included the change in fasting plasma glucose level.
Summary · context
Patients who were 10 to less than 17 years of age were randomly assigned, in a 1:1 ratio, to receive subcutaneous liraglutide (up to 1.8 mg per day) or placebo for a 26-week double-blind period, followed by a 26-week open-label extension period.
Summary · context
All the patients received metformin during the trial.
Report a problemFND-3103418403
03HumanRandomized controlled trialEfficacy outcome
In youth with type 2 diabetes taking metformin, the HbA1c difference between liraglutide and placebo increased to -1.30 percentage points by 52 weeks.
In plain wordsIn children and teenagers with type 2 diabetes on metformin, liraglutide kept HbA1c lower than placebo at 52 weeks.
Peptide
Liraglutide
Outcome
DecreaseHbA1c treatment difference at 52 weeks
Study
n = 134
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
up to 1.8 mg per day · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Estimated treatment difference
−1.3 percentage points
52 weeks
Source sentences
Summary
the difference increased to -1.30 percentage points by 52 weeks
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who were 10 to less than 17 years of age were randomly assigned, in a 1:1 ratio, to receive subcutaneous liraglutide (up to 1.8 mg per day) or placebo for a 26-week double-blind period, followed by a 26-week open-label extension period.
Summary · context
All the patients received metformin during the trial.
Report a problemFND-3103418402
04HumanRandomized controlled trialSafety outcome
In youth with type 2 diabetes, the number of patients who reported adverse events was similar with liraglutide and with placebo.
In plain wordsIn children and teenagers with type 2 diabetes, about the same number of patients reported side effects with liraglutide as with placebo.
Peptide
Liraglutide
Outcome
No significant changePatients reporting any adverse event
Study
n = 134
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
up to 1.8 mg per day · subcutaneous · 26 weeksAs given in this study (human).
Measurements
Patients with adverse events
84.8%
liraglutide
Patients with adverse events
80.9%
placebo
Source sentences
Summary
The number of patients who reported adverse events was similar in the two groups (56 [84.8%] with liraglutide and 55 [80.9%] with placebo)
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who were 10 to less than 17 years of age were randomly assigned, in a 1:1 ratio, to receive subcutaneous liraglutide (up to 1.8 mg per day) or placebo for a 26-week double-blind period, followed by a 26-week open-label extension period.
Summary · context
All the patients received metformin during the trial.
Report a problemFND-3103418404
05HumanRandomized controlled trialSafety outcome
In youth with type 2 diabetes, the overall rate of adverse events was higher with liraglutide than with placebo.
In plain wordsIn children and teenagers with type 2 diabetes, side effects happened more often with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseOverall rate of adverse events
Study
n = 134
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
up to 1.8 mg per day · subcutaneous · 26 weeksAs given in this study (human).
Source sentences
Summary
the overall rates of adverse events and gastrointestinal adverse events were higher with liraglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who were 10 to less than 17 years of age were randomly assigned, in a 1:1 ratio, to receive subcutaneous liraglutide (up to 1.8 mg per day) or placebo for a 26-week double-blind period, followed by a 26-week open-label extension period.
Summary · context
All the patients received metformin during the trial.
Report a problemFND-3103418405
06HumanRandomized controlled trialSafety outcome
In youth with type 2 diabetes, the rate of gastrointestinal adverse events was higher with liraglutide than with placebo.
In plain wordsIn children and teenagers with type 2 diabetes, stomach and gut side effects happened more often with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseGastrointestinal adverse events rate
Study
n = 134
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
up to 1.8 mg per day · subcutaneous · 26 weeksAs given in this study (human).
Source sentences
Summary
the overall rates of adverse events and gastrointestinal adverse events were higher with liraglutide.
3 context sentences(design, population, supporting numbers)
Summary · context
This efficacy came at the cost of an increased frequency of gastrointestinal adverse events.
Summary · context
Patients who were 10 to less than 17 years of age were randomly assigned, in a 1:1 ratio, to receive subcutaneous liraglutide (up to 1.8 mg per day) or placebo for a 26-week double-blind period, followed by a 26-week open-label extension period.
Summary · context
All the patients received metformin during the trial.
Report a problemFND-3103418406

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, 12:10 UTC
Study results updated
Version 1
9 Oct 2026, 03:05 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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