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

NCT02803918 · Completed

Last updated 2026-05-28

This clinical trial is testing the safety and effects of the medication lixisenatide in children and adolescents with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, single-blind treatment study

Participants 23 people

Who can join Ages 10–17 · all sexes

Timeline Started 2017-05 · est. completion 2020-01

Where 11 sites · Mauritius, Mexico, South Africa, Spain, Turkey (Türkiye), United States

What this study is testing ClinicalTrials.gov NCT02803918 ↗

Description as written by the study sponsor.

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.

Treatments tested

Lixisenatide (AVE0010) Drug

Pharmaceutical form: solution Route of administration: subcutaneous
Placebo Drug

Pharmaceutical form: solution Route of administration: subcutaneous
Basal Insulin Drug

Pharmaceutical form: solution Route of administration: subcutaneous
Metformin Drug

Pharmaceutical form: tablet Route of administration: oral

Main thing measured	Number of patients with adverse events (AEs)
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02803918 ↗