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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Pharmaceutical form:Solution for injection Route of administration: subcutaneous
Pharmaceutical form:Solution for injection Route of administration: subcutaneous
Investigational Site Number 840005
Chula Vista, California, United States
Investigational Site Number 840001
Overland Park, Kansas, United States
Investigational Site Number 840003
Louisville, Kentucky, United States
Investigational Site Number 484001
Puebla City, Mexico
Investigational Site Number 710002
Cape Town, South Africa
Investigational Site Number 826001
Leeds, United Kingdom
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
Time frame: D1 at each period up to 4h30 after study drug injection (8 timepoints)
Pharmacokinetics: lixisenatide plasma concentration
Time frame: 0 (predose), 30 min, 1h, 1h30, 2h30, 3h30, 4h30 and 6h30 post-dose at D1 of each study period (8 timepoints)
Pharmacokinetic parameter (Cmax)
Time frame: calculated over the period of timepoints at D1 of each study period
Pharmacokinetic parameter (Tmax)
Time frame: calculated over the period of timepoints at D1 of each study period
Pharmacokinetic parameter (AUC last)
Time frame: estimated over the period of timepoints at D1 of each study period
Pharmacokinetic parameter (AUC)
Time frame: 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
Time frame: D1 at each period up to 4h30 after study drug injection (7 timepoints)
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