Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin

NCT01169779 · Completed

Last updated 2026-05-28

This clinical trial tested the drug lixisenatide in adults with type 2 diabetes whose blood sugar levels were not well controlled by metformin alone.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 391 people

Who can join Ages 18+ · all sexes

Timeline Started 2010-07 · est. completion 2011-12

Where 35 sites · China, Hong Kong, Malaysia, Thailand

What this study is testing ClinicalTrials.gov NCT01169779 ↗

Description as written by the study sponsor.

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010) in comparison to placebo, as an add-on treatment to metformin with or without sulfonylurea, over a period of 24 weeks of treatment. The primary objective is to assess the effects on glycemic control of lixisenatide (AVE0010) in comparison to placebo as an add-on treatment to metformin with or without sulfonylurea in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide over 24 weeks on percentage of patients reaching HbA1c less than (\< ) 7 percent (%) or HbA1c less than or equal to (\<=) 6.5%, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) and glucose excursion during standardized meal test, body weight; to evaluate safety, tolerability, pharmacokinetic (PK) and anti-lixisenatide antibody development.

Treatments tested

Lixisenatide (AVE0010) Drug

Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Placebo Drug

Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Pen auto-injector also known as OptiClik® Device
Metformin Drug

Metformin to be continued at stable dose (at least 1.0 gram per day and not more than 1.5 gram per day) up to Week 24.
Sulfonylurea Drug

Sulfonylurea if given at screening, to be continued up to Week 24. In patients with a screening HbA1c \<8% the dose is decreased by 25% to 50% at randomization and then increased up to the screening dose between Week 4 and 12 as per fasting self-monitored plasma glucose (SMPG) values. In patients with a screening HbA1c \>=8%, the dose is not to be changed at randomization. In any case, after Week 12, sulfonylurea is to be continued at a stable dose.

Main thing measured	Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01169779 ↗