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Trial · Interventional

CompletedPhase 1Registry data

A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)

NCTNCT02803918 (opens ClinicalTrials.gov in a new tab)Other idTDR14311Other idU1111-1176-6142
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
23 participants (actual)
Sponsor
Sanofi · Industry
Design
Randomized · Single masking
Countries
6 countries

United States, Mauritius, Mexico, South Africa, Spain, Turkey (Türkiye)

Start
17 May 2017
Primary completion
27 Jan 2020
Completion
27 Jan 2020
First posted
17 Jun 2016 (estimated)
Last update posted
25 Apr 2022
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20172018201920202021
  1. Ph 1

    A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)

    NCT02803918

    17 May 2017 to 27 Jan 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Primary Objective: To demonstrate safety of 14-day repeated lixisenatide doses with 3 ascending doses as compared to placebo in pediatric patients with T2DM. Secondary Objectives: * To evaluate plasma concentrations of lixisenatide after repeated doses (3 ascending doses) and pharmacokinetic parameters of repeated lixisenatide doses in pediatric patients with T2DM. * To evaluate the change from baseline in fasting and post-prandial plasma glucose concentrations during a standardized meal test after 3 ascending repeated doses of lixisenatide in comparison to placebo.

Interventions

  • Lixisenatide (AVE0010)Drug
  • PlaceboDrug
  • Basal InsulinDrug
  • MetforminDrug

Arms2

  • Experimental

    Lixisenatide

    Administration of 3 ascending repeated doses of lixisenatide once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.

  • Placebo comparator

    Placebo

    Administration of 3 ascending repeated doses of matching placebo once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Number of patients with adverse events (AEs)

    Time frame · Up to 10 weeks

  2. Number of patients with treatment-emergent adverse events (TEAEs)

    Time frame · Up to 10 weeks

  3. Number of patients with anti-lixisenatide antibodies

    Time frame · Up to 10 weeks

Secondary outcomes(6)

  1. Assessment of pharmacokinetic (PK) parameters: lixisenatide plasma concentration

    Time frame · Day 14, Day 28 and Day 42

  2. Assessment of PK parameters: maximum concentration (Cmax)

    Time frame · Day 42

  3. Assessment of PK parameters: time to reach Cmax (Tmax)

    Time frame · Day 42

  4. Assessment of PK parameters: area under up to last concentration (AUClast)

    Time frame · Day 42

  5. Assessment of PK parameters: area under curve (AUC)

    Time frame · Day 42

  6. Assessment of pharmacodynamic parameter: plasma glucose AUC-0-4.5 hours

    Time frame · Day 14, Day 28 and Day 42

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

13 results

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

Barrientos-Pérez et al. 2022Pediatric diabetescited by 15

PMID 35411611PMC9790255DOI 10.1111/pedi.13343PUB-35411611

Free to read · publisher termsCC BY-NC13 results
Read at sourceSee results (13)

Eligibility

Who could join, as posted.

Sex
All
Age
from 10 Years up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria : * Male or female patients aged ≥10 and \<18 years old (at least 4 patients below 16 years old). * Body mass index (BMI) \>85th percentile for age and gender; BMI ≤50 kg/m2. * Male and female patients with documented T2DM insufficiently controlled with metformin at a stable dose and regimen for 8 weeks prior to randomization and/or basal insulin at stable dose (± 20%) and regimen for 8 weeks prior to randomization. The exact individual metformin dose will be selected according to local regulation and to the investigator's medical judgment. * Glycated hemoglobin (HbA1c) \>6.5% and ≤11% at screening. Exclusion criteria: * If female, ongoing pregnancy (defined as positive serum pregnancy test), breast-feeding. * Sexually active postmenarchal female patient who does not agree to use an adequate and highly effective method of contraception throughout the study duration and according to local regulation (ie, hormonal contraception, condom, etc.). * Diabetes other than T2DM. * Fasting plasma glucose \>250 mg/dL (\>13.9 mmol/L) at screening. * Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin and basal insulin (eg, alpha glucosidase inhibitor, glucagon-like peptide (GLP-1) receptor agonist, dipeptidyl peptidase-IV (DPP-IV) inhibitors, short-acting insulin etc.) within 1 month prior to the screening visit. * History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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