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

NCT02803918 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-04-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Placebo

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Basal Insulin

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Metformin

Pharmaceutical form: tablet Route of administration: oral

DRUG

Lixisenatide (AVE0010)

Pharmaceutical form: solution Route of administration: subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-17
Primary Completion
2020-01-27
Completion
2020-01-27
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02803918 on ClinicalTrials.gov