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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Lixisenatide (AVE0010); Drug: Placebo; Drug: Basal Insulin; Drug: Metformin

• Registration Number: NCT02803918
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Study Start: 2017-05-17
• Primary Completion: 2020-01-27
• Study Completion: 2020-01-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lixisenatide	Lixisenatide (AVE0010)	Administration of 3 ascending repeated doses of lixisenatide once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.
Placebo	Placebo	Administration of 3 ascending repeated doses of matching placebo once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.
Placebo	Basal Insulin	Administration of 3 ascending repeated doses of matching placebo once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.
Placebo	Metformin	Administration of 3 ascending repeated doses of matching placebo once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.
Lixisenatide	Metformin	Administration of 3 ascending repeated doses of lixisenatide once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.
Lixisenatide	Basal Insulin	Administration of 3 ascending repeated doses of lixisenatide once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events (AEs)	Up to 10 weeks
Number of patients with treatment-emergent adverse events (TEAEs)	Up to 10 weeks
Number of patients with anti-lixisenatide antibodies	Up to 10 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment of PK parameters: maximum concentration (Cmax)	Day 42
Assessment of pharmacokinetic (PK) parameters: lixisenatide plasma concentration	Day 14, Day 28 and Day 42
Assessment of PK parameters: time to reach Cmax (Tmax)	Day 42
Assessment of PK parameters: area under up to last concentration (AUClast)	Day 42
Assessment of PK parameters: area under curve (AUC)	Day 42
Assessment of pharmacodynamic parameter: plasma glucose AUC-0-4.5 hours	Day 14, Day 28 and Day 42

Trial Locations

Locations (11)

Investigational Site Number 840006; 🇺🇸 New Orleans, Louisiana, United States

Investigational Site Number 792002; 🇹🇷 Ankara, Turkey

Investigational Site Number 840002; 🇺🇸 Baton Rouge, Louisiana, United States

Investigational Site Number 840009; 🇺🇸 Philadelphia, Pennsylvania, United States

Investigational Site Number 840007; 🇺🇸 Lufkin, Texas, United States

Investigational Site Number 480001; 🇲🇺 Phoenix, Mauritius

Investigational Site Number 484001; 🇲🇽 Monterrey, Mexico

Investigational Site Number 484002; 🇲🇽 Puebla, Mexico

Investigational Site Number 710001; 🇿🇦 Cape Town, South Africa

Investigational Site Number 724002; 🇪🇸 Barcelona, Spain

Investigational Site Number 792001; 🇹🇷 Izmir, Turkey