Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

NCT01517412 · Completed

Last updated 2026-05-28

This clinical trial compared the effects of two different injection times of lixisenatide (before the main meal of the day versus before breakfast) in adults with type 2 diabetes who were already taking metformin.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 451 people

Who can join Ages 18+ · all sexes

Timeline Started 2012-02 · est. completion 2013-05

Where 82 sites · Canada, Czechia, France, Germany, Poland, Romania, Russia, Spain, Ukraine, United States

What this study is testing ClinicalTrials.gov NCT01517412 ↗

Description as written by the study sponsor.

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

Treatments tested

Lixisenatide (AVE0010) Drug

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
Self-injector pen device (OptiClik®) Device
Metformin also known as Route of administration: Oral Drug

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

Main thing measured	Change in HbA1c From Baseline to Week 24
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01517412 ↗