Evidence map›Paper›PMID 35411611›Full record

Trial reportPediatric diabetes2022

A study on pharmacokinetics, pharmacodynamics and safety of lixisenatide in children and adolescents with type 2 diabetes.

Margarita Barrientos-Pérez, Daniel S Hsia, Lance Sloan, Haylene Nell, Ounisha Mungur, Lionel Hovsepian, Wolfgang Schmider, Robert Spranger, Na Yang, Elisabeth Niemoeller

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatric diabetes, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02803918. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 18% 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.

NCT02803918 phase1completed

Randomized, Double-blind, Placebo-controlled, Dose Escalation, Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin and/or Basal Insulin

Ran2017Enrolled23Registered outcomes9Posted comparisons0ConditionsType 2 Diabetes MellitusArmsBasal Insulin, Lixisenatide (AVE0010), Metformin, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Review
  8. 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

10 authors at 8 institutions in 7 countries.

Margarita Barrientos-PérezDepartment of Paediatric Endocrinology, Angeles Hospital of Puebla, Puebla City, Mexico.
Daniel S HsiaPennington Biomedical Research Center, Baton Rouge, Louisiana, USA.ORCID 0000-0003-2832-3429
Lance SloanTexas Institute for Kidney and Endocrine Disorders, Lufkin, Texas, USA.
Haylene NellTiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa.
Ounisha MungurCAP Research, Quatre Bornes, Mauritius.
Lionel HovsepianSanofi, Paris, France.
Wolfgang SchmiderSanofi, Frankfurt, Germany.
Robert SprangerSanofi, Frankfurt, Germany.
Na YangSanofi, Beijing, China.
Elisabeth NiemoellerSanofi, Frankfurt, Germany.
Sanofi (Germany) · DEClínica Ruiz · MXKarl Bremer Hospital · ZALankenau Institute for Medical Research · USMinistry of Health and Quality of Life · MUPennington Biomedical Research Center · USSanofi (China) · CNSanofi (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this study was to investigate the pharmacokinetic, pharmacodynamic and safety profile of the glucagon-like peptide-1 receptor agonist, lixisenatide, for the treatment of type 2 diabetes (T2D) in pediatric individuals. MATERIALS AND

methodsIn this Phase 1, multicenter, randomized, double-blind, placebo-controlled, parallel-group, ascending repeated dose study (NCT02803918), participants aged ≥10 and < 18 years were randomized 3:1 to receive once-daily lixisenatide in 2-week increments of 5, 10, and 20 μg (n = 18) or placebo (n = 5) for 6 weeks.

resultsMean lixisenatide concentrations generally increased with increasing doses irrespective of anti-drug antibody (ADA) status; however, mean lixisenatide concentrations and inter-subject variability were higher for participants with positive ADA status. Improvements in fasting plasma glucose, post-prandial glucose, AUC

conclusionsMean lixisenatide concentrations generally increased with increasing dose, irrespective of ADA status. Lixisenatide was associated with improved glycemic control and a trend in body weight reduction compared with placebo. The safety and tolerability profile of repeated lixisenatide doses of up to 20 μg per day in children and adolescents with T2D was reflective of the established safety profile of lixisenatide in adults.

Indexed as

Diabetes Mellitus, Type 2Hypoglycemic AgentsPeptidesAdolescentBlood GlucoseBody WeightChildDouble-Blind MethodGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHumansHypoglycemiaTreatment OutcomeBlood GlucoseGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHypoglycemic AgentslixisenatidePeptidesantidiabetic drugclinical trialpharmacodynamicspharmacokineticstype 2 diabetes

Identifiers

PMID35411611
PMCPMC9790255
OpenAlexW4223445125

What Socratic holds

Textmetadata
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.