Study S001162

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

ClinicalTrials.gov record

Registration

Registration: NCT01572649
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 24
Start: 2012-05
Primary completion: 2014-03
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Lixisenatide (AVE0010); DRUG:Placebo
Results posted: FALSE
Secondary identifiers: EUDRACT_NUMBER:2011-004584-67; OTHER:U1111-1124-3136

Registered primary outcomes

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)]

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