Evidence map›Paper›PMID 25603819›Full record

Trial reportClinical pharmacokinetics2015

Comparable liraglutide pharmacokinetics in pediatric and adult populations with type 2 diabetes: a population pharmacokinetic analysis.

Kristin C Carlsson Petri, Lisbeth V Jacobsen, David J Klein

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacokinetics, 2015. 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 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% 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 25036533other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Observational
  6. Diabetic kidney disease in children and adolescents: an update.Pediatric nephrology (Berlin, Germany) · 2022
    Review
  7. Article
  8. Clinical Impact of Liraglutide as a Treatment of Obesity.Clinical pharmacology : advances and applications · 2021
    Review
  9. Medications for the treatment of obesity in adolescents.Therapeutic advances in endocrinology and metabolism · 2020
    Review
  10. Review
  11. Article
  12. Article
  13. Modeling energy intake and body weight effects of a long-acting amylin analogue.Journal of pharmacokinetics and pharmacodynamics · 2018
    Article
  14. Review
  15. Review
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

3 authors at 2 institutions in 2 countries.

Kristin C Carlsson PetriGlobal Development, Clinical Pharmacology, Novo Nordisk A/S, 108-110 Vandtårnsvej, 2860, Søborg, Denmark, KCC@novonordisk.com.
Lisbeth V Jacobsen
David J Klein
Novo Nordisk (Denmark) · DKMedpace (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe safety, tolerability, and pharmacokinetics of the once-daily human glucagon-like peptide-1 (GLP-1) analog liraglutide have been evaluated in pediatric patients aged greater than 10 years with type 2 diabetes (T2D). In this study, a population pharmacokinetic analysis was compared to the pediatric pharmacokinetic data with those from two clinical pharmacology trials in adults with T2D.

methodsA one-compartment pharmacokinetic model previously found to adequately describe the pharmacokinetics of liraglutide in adults with T2D was applied to the evaluation of 13 pediatric subjects (10-17 years of age) with T2D. Steady-state estimates for apparent clearance (CL/F) for individual subjects and corresponding dose were used to derive the area under the plasma-concentration time curve from 0-24 h (AUC24) and investigate dose proportionality in the pediatric trial. A covariate analysis evaluated the effects of body weight, gender, and age category (pediatric/adult) on liraglutide exposure.

resultsDose proportionality in the dose range of 0.3-1.8 mg was indicated by the model-derived AUC24 slope: 1.05 (95% CI 0.96-1.15). Consistent with findings from adult trials, body weight and gender were relevant covariates for liraglutide exposure in the pediatric population. The CL/F estimates, and thus exposure, for the pediatric subjects with T2D were similar to those in the adult trials.

conclusionBased on this population pharmacokinetic analysis, the liraglutide dose regimen that was found to be clinically effective in adults is predicted to achieve the same range of exposure in the pediatric population (10-17 years of age) with a pre-trial body weight range of 57-214 kg.

Indexed as

AdolescentAdultAgedBlood GlucoseBody WeightChildCross-Over StudiesDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodFemaleGlycated HemoglobinHumansHypoglycemic AgentsLiraglutideMaleBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsLiraglutide

Identifiers

PMID25603819
PMCPMC4449373
OpenAlexW2077220482

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
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.