Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin

NCT01596504 · Completed

Last updated 2026-05-28

This clinical trial compared the effects of two diabetes medications, lixisenatide and liraglutide, in adults with type 2 diabetes whose blood sugar was not well controlled with insulin glargine, with or without metformin.

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 142 people

Who can join Ages 18–75 · all sexes

Timeline Started 2012-05 · est. completion 2013-07

Where 8 sites · Germany

What this study is testing ClinicalTrials.gov NCT01596504 ↗

Description as written by the study sponsor.

Primary Objective: \- To investigate the effects of repeated subcutaneous doses of lixisenatide 20 μg once daily (QD) as compared to liraglutide 1.2 mg QD or 1.8 mg QD in reducing post-prandial plasma glucose (PPG) assessed as area under the plasma glucose-concentration-time curve (AUC) after a standardized breakfast at the end of a 8-week treatment period in participants with type 2 diabetes mellitus (T2DM) not adequately controlled with insulin glargine (± metformin). Secondary Objectives: * To assess the effects of lixisenatide 20 μg QD as compared to liraglutide 1.2 QD or 1.8 mg QD after an 8-week treatment period in participants with T2DM not adequately controlled with insulin glargine (± metformin) on: * Post-prandial C-peptide, glucagon and appetite perceptions after a standardized breakfast, * Appetite perceptions after standardized dinner, * Gastric emptying after a standardized labelled test meal, * Fasting plasma glucose, 24-hour plasma glucose profile, * Glycosylated hemoglobin (HbA1c), * Insulin glargine dose, * 7-point self monitored plasma glucose (SMPG), * Body weight and waist circumference, * 24-hour heart rate and blood pressure, * To assess lixisenatide and liraglutide safety and tolerability as add on treatment to insulin glargine (± metformin).

Treatments tested

Lixisenatide (AVE0010) Drug

Pharmaceutical form: solution for injection self-administered with a pen-like injector (OptiClik®). Route of administration: subcutaneous
Liraglutide also known as Victoza® Drug

Pharmaceutical form:solution for injection Route of administration: subcutaneous
Insulin Glargine also known as Lantus® SoloSTAR® Drug

Doses to be adjusted to maintain a fasting self-measured plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL)
Metformin Drug

If previously taken metformin to be continued at stable dose throughout the study

Main thing measured	Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	liraglutide, lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01596504 ↗