NCT02803918

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

Randomized, Double-blind, Placebo-controlled, Dose Escalation, Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin and/or Basal Insulin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The total study duration will be up to 10 weeks that includes a 6-week treatment period with dose escalation every 2 weeks.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Lixisenatide (AVE0010)	Pharmaceutical form: solution Route of administration: subcutaneous
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

Timeline

• Start date: 2017-05-17
• Primary completion: 2020-01-27
• Completion: 2020-01-27
• First posted: 2016-06-17
• Last updated: 2022-04-25

Locations

11 sites across 6 countries: United States, Mauritius, Mexico, South Africa, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study