Effects of Lixisenatide Compared to Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes

NCT01175473 · Completed

Last updated 2026-05-28

This clinical trial compares the effects of two diabetes medications, lixisenatide and liraglutide, on blood sugar levels after meals in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

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

Participants 148 people

Who can join Ages 18–74 · all sexes

Timeline Started 2010-08 · est. completion 2010-11

Where 7 sites · Germany

What this study is testing ClinicalTrials.gov NCT01175473 ↗

Description as written by the study sponsor.

The purpose of the study is to compare the pharmacodynamic effects of lixisenatide (AVE0010), in comparison to liraglutide, as an add-on treatment to metformin, over a period of 4 weeks of treatment. The primary objective is to assess the effects of lixisenatide, in comparison to liraglutide, in reducing postprandial plasma glucose (PPG) assessed as area under the plasma glucose concentration curve (AUC) after a standardized breakfast at Week 4. The secondary objectives are to assess the effects of lixisenatide on the maximum PPG excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast, 24-hour profile of plasma glucose, glycosylated hemoglobin (HbA1c), satiety markers (obestatin, peptide YY \[PYY3-36\] and oxyntomodulin); and to assess the clinical and laboratory safety profile.

Treatments tested

Lixisenatide (AVE0010) Drug

Self administered by subcutaneous injections once daily 30 minutes before breakfast.
Pen auto-injector also known as OptiClik® Device
Liraglutide Drug

Self administered by subcutaneous injections once daily 30 minutes before breakfast.
Pre-filled pen injector also known as Victoza® Device
Metformin Drug

Metformin to be continued at stable dose (1.5 gram per day) up to Week 4.

Main thing measured	Change From Baseline in Area Under the Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h) at Day 28
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	liraglutide, lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01175473 ↗