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

Phase 1

Completed

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

• Registration Number: NCT01572649
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

The duration of the study for each patient is planned between 4 and 7 weeks including a screening period (25 to 30 days), 3 treatment periods 1-7 days apart, each period lasting only one day (Day 1) and an end-of-study visit between 1 to 7 days after the last dose administration.

Study Timeline

• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Study Start: 2012-05
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-22
• Last Update Posted: 2014-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1 single administration (volume matched to the dose lixisenatide: 50 µL or 100µL) once a day subcutaneously
Dose 1	Lixisenatide (AVE0010)	1 single administration of 5 µg lixisenatide (50 µL) once a day subcutaneously
Dose 2	Lixisenatide (AVE0010)	1 single administration of 10 µg lixisenatide (100 µL) once a day subcutaneously

Primary Outcome Measures

Name	Time	Method
GLU-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	D1 at each period up to 4h30 after study drug injection (8 timepoints)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: lixisenatide plasma concentration	0 (predose), 30 min, 1h, 1h30, 2h30, 3h30, 4h30 and 6h30 post-dose at D1 of each study period (8 timepoints)
Pharmacokinetic parameter (Cmax)	calculated over the period of timepoints at D1 of each study period
Pharmacokinetic parameter (Tmax)	calculated over the period of timepoints at D1 of each study period
Pharmacokinetic parameter (AUC last)	estimated over the period of timepoints at D1 of each study period
Pharmacokinetic parameter (AUC)	extrapolated based on the period of timepoints at D1 of each study period
Area under the concentration time profile from time of standardized breakfast start (30 min after IMP injection) until 4 hours later for insulin, C-peptide and glucagon	D1 at each period up to 4h30 after study drug injection (7 timepoints)

Trial Locations

Locations (6)

Investigational Site Number 840001; 🇺🇸 Overland Park, Kansas, United States

Investigational Site Number 840003; 🇺🇸 Louisville, Kentucky, United States

Investigational Site Number 826001; 🇬🇧 Leeds, United Kingdom

Investigational Site Number 840005; 🇺🇸 Chula Vista, California, United States

Investigational Site Number 710002; 🇿🇦 Cape Town, South Africa

Investigational Site Number 484001; 🇲🇽 Puebla, Mexico