GLPwatch

Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes

NCT01572649 · Completed

Last updated 2026-05-28

This clinical trial is testing how the drug lixisenatide affects blood sugar levels and safety in both children and adults 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, double-blind treatment study
Participants 24 people
Who can join Ages 10–65 · all sexes
Timeline Started 2012-05 · est. completion 2014-03
Where 6 sites · Mexico, South Africa, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT01572649 ↗

Description as written by the study sponsor.

Primary Objective: \- To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls Secondary Objectives: \- To evaluate in both paediatric and adult populations: * the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single subcutaneous ascending doses * the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast * safety and tolerability.

Treatments tested

Main thing measuredGLU-AUC 0:30-4:30h: area under the plasma glucose concentration time profile from time of the standardized breakfast start (30 min after IMP injection and pre-meal plasma glucose) until 4 hours later subtracting the pre-meal value
SponsorSanofi
Conditions studiedType 2 Diabetes Mellitus
GLP-1 drugs lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01572649 ↗