Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Paediatric (10 - 17 Years Old) and Adult Patients With Type 2 Diabetes
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. ;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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