Evidence map›Paper›PMID 25036533›Full record

Trial reportDiabetes technology & therapeutics2014

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

David J Klein, Tadej Battelino, D J Chatterjee, Lisbeth V Jacobsen, Paula M Hale, Silva Arslanian, NN2211-1800 Study Group

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes technology & therapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00943501. Cited by 39 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 6 pooled it
4.3field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00943501 phase1completed

Liraglutide: A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety/Tolerability, Pharmacokinetics & Pharmacodynamics of Liraglutide in Pediatric (10-17 Years Old) With Type 2 Diabetes

Ran2009Enrolled21Registered outcomes3Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2Armsliraglutide, Placebo
PMID 25603819other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 6 syntheses or guidelines pooled it, 103 citations in OpenAlex.

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  3. New Perspectives in Modulating the Entero-Insular Axis in Pediatric Obesity.International journal of molecular sciences · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 4 countries.

David J Klein1 Cincinnati Children's Hospital Medical Center , Cincinnati, Ohio.
Tadej Battelino
D J Chatterjee
Lisbeth V Jacobsen
Paula M Hale
Silva Arslanian
NN2211-1800 Study Group
Novo Nordisk (United States) · USChildren's Hospital of Pittsburgh · USCincinnati Children's Hospital Medical Center · USNovo Nordisk (Denmark) · DKUniversity of Ljubljana · SI

Funding

Medical Research Council G0800661
6 · The paper itself

Abstract

backgroundThe prevalence of type 2 diabetes (T2D) in youth is increasing. Treatment options beyond metformin and insulin are needed. The safety, tolerability, pharmacokinetics, and pharmacodynamics of liraglutide once daily in youth (10-17 years old) with T2D were investigated in a randomized, double-blind, placebo-controlled trial. SUBJECTS AND

methodsYouth 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). Starting at 0.3 mg/day, doses were escalated weekly to 0.6, 0.9, 1.2, and 1.8 mg/day (or placebo equivalent) for 5 weeks.

resultsNineteen participants completed the trial. Baseline characteristics were similar between groups, with mean (SD) values for age of 14.8 (2.2) years, weight of 113.2 (35.6) kg (range, 57-214 kg), diabetes duration of 1.7 (1.4) years, and HbA1c level of 8.1% (1.2%). No serious adverse events (AEs), including severe hypoglycemia, occurred. Transient gastrointestinal AEs were most common at lower liraglutide doses during dose escalation. No significant changes in safety and tolerability parameters occurred. There was no evidence of pancreatitis or lipase elevations above three times the upper normal limit; calcitonin levels remained within the normal range. For liraglutide 1.8 mg, mean half-life was 12 h, and clearance was 1.7 L/h. After 5 weeks, the decline in HbA1c level was greater with liraglutide versus placebo (-0.86 vs. 0.04%, P=0.0007), whereas mean body weight remained stable (-0.50 vs. -0.54 kg, P=0.9703).

conclusionsLiraglutide was well tolerated in youth with T2D, with safety, tolerability, and pharmacokinetic profiles similar to profiles in adults.

Indexed as

AdolescentAge of OnsetBelgiumBlood GlucoseBody WeightChildDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodGlucagon-Like Peptide 1Glycated HemoglobinHumansHypoglycemic AgentsLiraglutidePediatric ObesityPrevalenceBlood GlucoseGlucagon-Like Peptide 1Glycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsLiraglutide

Identifiers

PMID25036533
PMCPMC4183917
OpenAlexW2050053279

What Socratic holds

Texttitle and abstract
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.