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

• Status: Completed
• Trial end date: 2020-01-27

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.

• Phase: Phase 1

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin, Globin Zinc; Lixisenatide; Metformin