Liraglutide's safety, tolerability, pharmacokinetics, and pharmacodynamics in pediatric type 2 diabetes: a randomized, double-blind, placebo-controlled trial.

Klein DJ, Battelino T, Chatterjee DJ, Jacobsen LV, Hale PM, Arslanian S

Diabetes technology & therapeutics18 Jul 2014Cited by 84 (Europe PMC)

PMID25036533PMCIDPMC4183917DOI10.1089/dia.2013.0366PepBankPUB-25036533

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 study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In youth with type 2 diabetes, HbA1c declined more with liraglutide than with placebo after 5 weeks.
In plain wordsIn young people with type 2 diabetes, HbA1c fell more with liraglutide than with placebo after 5 weeks.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change after 5 weeks
Study
n = 19
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.3 to 1.8 mg/day, escalated weekly · 5 weeksAs given in this study (human).
Measurements
HbA1c change
−0.86%
liraglutide
HbA1c change
0.04%
placebo
Source sentences
Summary
After 5 weeks, the decline in HbA1c level was greater with liraglutide versus placebo (-0.86 vs. 0.04%, P=0.0007)
1 context sentence(design, population, supporting numbers)
Summary · context
Youth treated with diet/exercise alone or with metformin and having a hemoglobin A1c (HbA1c) level of 6.5-11% were randomized to liraglutide (n=14) or placebo (n=7).
Report a problemFND-2503653308
02HumanRandomized controlled trialEfficacy outcome
In youth with type 2 diabetes, mean body weight remained stable, with no difference between liraglutide and placebo after 5 weeks.
In plain wordsIn young people with type 2 diabetes, body weight stayed stable and did not differ between liraglutide and placebo over 5 weeks.
Peptide
Liraglutide
Outcome
No significant changeBody weight change after 5 weeks
Study
n = 19
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
0.3 to 1.8 mg/day, escalated weekly · 5 weeksAs given in this study (human).
Measurements
Body weight change
−0.5 kg
liraglutide
Body weight change
−0.54 kg
placebo
Source sentences
Summary
whereas mean body weight remained stable (-0.50 vs. -0.54 kg, P=0.9703).
1 context sentence(design, population, supporting numbers)
Summary · context
Youth treated with diet/exercise alone or with metformin and having a hemoglobin A1c (HbA1c) level of 6.5-11% were randomized to liraglutide (n=14) or placebo (n=7).
Report a problemFND-2503653309
03HumanRandomized controlled trialSafety outcome
In youth with type 2 diabetes, no serious adverse events, including severe hypoglycemia, occurred during 5 weeks of liraglutide or placebo.
In plain wordsIn young people with type 2 diabetes, no serious side effects, including severe low blood sugar, occurred in this small short trial.
Peptide
Liraglutide
Outcome
No significant changeSerious adverse events and severe hypoglycemia
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.3 to 1.8 mg/day, escalated weekly · 5 weeksAs given in this study (human).
Source sentences
Summary
No serious adverse events (AEs), including severe hypoglycemia, occurred.
1 context sentence(design, population, supporting numbers)
Summary · context
Youth treated with diet/exercise alone or with metformin and having a hemoglobin A1c (HbA1c) level of 6.5-11% were randomized to liraglutide (n=14) or placebo (n=7).
Report a problemFND-2503653301
04HumanRandomized controlled trialSafety outcome
In youth with type 2 diabetes, transient gastrointestinal adverse events were most common at lower liraglutide doses during dose escalation.
In plain wordsIn young people with type 2 diabetes on liraglutide, short-lived stomach and gut side effects were most common at lower doses during dose increases.
Peptide
Liraglutide
Outcome
Not applicableGastrointestinal adverse events
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.3 to 1.8 mg/day, escalated weekly · 5 weeksAs given in this study (human).
Source sentences
Summary
Transient gastrointestinal AEs were most common at lower liraglutide doses during dose escalation.
1 context sentence(design, population, supporting numbers)
Summary · context
Youth treated with diet/exercise alone or with metformin and having a hemoglobin A1c (HbA1c) level of 6.5-11% were randomized to liraglutide (n=14) or placebo (n=7).
Report a problemFND-2503653302
05HumanRandomized controlled trialSafety outcome
In youth with type 2 diabetes, no significant changes in safety and tolerability parameters occurred.
In plain wordsIn young people with type 2 diabetes, safety and tolerability measures showed no significant changes.
Peptide
Liraglutide
Outcome
No significant changeSafety and tolerability parameters
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.3 to 1.8 mg/day, escalated weekly · 5 weeksAs given in this study (human).
Source sentences
Summary
No significant changes in safety and tolerability parameters occurred.
1 context sentence(design, population, supporting numbers)
Summary · context
Youth treated with diet/exercise alone or with metformin and having a hemoglobin A1c (HbA1c) level of 6.5-11% were randomized to liraglutide (n=14) or placebo (n=7).
Report a problemFND-2503653303
06HumanRandomized controlled trialSafety outcome
In youth with type 2 diabetes, liraglutide treatment showed no evidence of pancreatitis or lipase elevations above three times the upper normal limit.
In plain wordsIn young people with type 2 diabetes, there was no sign of pancreatitis or large rises in the enzyme lipase.
Peptide
Liraglutide
Outcome
No significant changePancreatitis and lipase elevation
Study
n: not reported in source
Outcome group
Adverse events · Gastrointestinal
Studied dose
0.3 to 1.8 mg/day, escalated weekly · 5 weeksAs given in this study (human).
Source sentences
Summary
There was no evidence of pancreatitis or lipase elevations above three times the upper normal limit
1 context sentence(design, population, supporting numbers)
Summary · context
Youth treated with diet/exercise alone or with metformin and having a hemoglobin A1c (HbA1c) level of 6.5-11% were randomized to liraglutide (n=14) or placebo (n=7).
Report a problemFND-2503653304
07HumanRandomized controlled trialSafety outcome
In youth with type 2 diabetes, calcitonin levels remained within the normal range during liraglutide treatment.
In plain wordsIn young people with type 2 diabetes on liraglutide, calcitonin levels stayed in the normal range.
Peptide
Liraglutide
Outcome
No significant changeCalcitonin level
Study
n: not reported in source
Outcome group
Adverse events · Endocrine and hormones
Studied dose
0.3 to 1.8 mg/day, escalated weekly · 5 weeksAs given in this study (human).
Source sentences
Summary
calcitonin levels remained within the normal range.
1 context sentence(design, population, supporting numbers)
Summary · context
Youth treated with diet/exercise alone or with metformin and having a hemoglobin A1c (HbA1c) level of 6.5-11% were randomized to liraglutide (n=14) or placebo (n=7).
Report a problemFND-2503653305
08HumanRandomized controlled trialPharmacokinetics
In youth with type 2 diabetes, liraglutide 1.8 mg had a mean half-life of 12 h.
In plain wordsIn young people with type 2 diabetes, liraglutide 1.8 mg had an average half-life of 12 hours.
Peptide
Liraglutide
Outcome
Not applicableMean half-life at 1.8 mg
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
1.8 mg · 5 weeksAs given in this study (human).
Measurements
Mean half-life
12 h
liraglutide 1.8 mg
Source sentences
Summary
For liraglutide 1.8 mg, mean half-life was 12 h
1 context sentence(design, population, supporting numbers)
Summary · context
Youth treated with diet/exercise alone or with metformin and having a hemoglobin A1c (HbA1c) level of 6.5-11% were randomized to liraglutide (n=14) or placebo (n=7).
Report a problemFND-2503653306
09HumanRandomized controlled trialPharmacokinetics
In youth with type 2 diabetes, liraglutide 1.8 mg had a clearance of 1.7 L/h.
In plain wordsIn young people with type 2 diabetes, the body cleared liraglutide 1.8 mg at 1.7 litres per hour.
Peptide
Liraglutide
Outcome
Not applicableClearance at 1.8 mg
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
1.8 mg · 5 weeksAs given in this study (human).
Measurements
Clearance
1.7 L/h
liraglutide 1.8 mg
Source sentences
Summary
For liraglutide 1.8 mg, mean half-life was 12 h, and clearance was 1.7 L/h.
1 context sentence(design, population, supporting numbers)
Summary · context
Youth treated with diet/exercise alone or with metformin and having a hemoglobin A1c (HbA1c) level of 6.5-11% were randomized to liraglutide (n=14) or placebo (n=7).
Report a problemFND-2503653307

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT00943501

Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

Novo Nordisk A/Sn = 21Nov 2009 to Sept 2011

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 26 Jan 2017

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

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