CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 451 enrolled
Drug / intervention
Lixisenatide (AVE0010) +2 moredrug
Likely dose
Metformin 1.5 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01517412
NCT01517412Phase 3Completed
CompareCT.gov

A 24-week, Open-label, Randomized, 2-arm Parallel Group, Multinational, Multi-center Clinical Trial to Compare the Efficacy and Safety of Lixisenatide Injected Prior to the Main Meal of the Day Versus Lixisenatide Injected Prior to Breakfast in Type 2 Diabetic Patients Not Adequately Controlled on Metformin

Sanofi·interventional·Posted Jan 25, 2012·Updated Oct 14, 2016

In Brief

A Phase 3 clinical trial evaluating Lixisenatide (AVE0010), Self-injector pen device (OptiClik®), and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 451 participants across 82 sites in 10 countries.

Detailed Summary

Primary Objective: \- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24) Secondary Objective: * To assess the effect of the 2 lixisenatide regimens on: * The percentage of participants who reached the target of HbA1c \< 7% or ≤ 6.5% at Week 24 * Fasting Plasma Glucose (FPG) * 7-point Self-Monitored Plasma Glucose (SMPG) profiles * Body weight * To assess the safety and tolerability of the 2 lixisenatide regimens

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesCanada, Czechia, France, Germany, Poland, Romania, Russia, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2012
Enrollment StartFeb 1, 2012
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.4 years ago

Interventions

Lixisenatide (AVE0010)drug

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous

Self-injector pen device (OptiClik®)device

Metformindrug

To be kept at stable dose (≥1.5 g/day) throughout the study.