Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin

NCT03798080 · Completed

Last updated 2026-05-28

This clinical trial compares the effects of a combination of insulin glargine and lixisenatide to insulin glargine alone in adults with type 2 diabetes whose blood sugar is not well controlled with basal insulin.

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 426 people

Who can join Ages 18+ · all sexes

Timeline Started 2019-02 · est. completion 2020-12

Where 45 sites · China

What this study is testing ClinicalTrials.gov NCT03798080 ↗

Description as written by the study sponsor.

Primary Objective: To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) to insulin glargine on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) who are not sufficiently controlled with basal insulin. Secondary Objectives: * To assess the effects of iGlarLixi in comparison with insulin glargine * To assess the safety in each treatment group

Treatments tested

Insulin glargine/Lixisenatide (HOE901/AVE0010) also known as Soliqua, iGlarLixi Drug

Pharmaceutical form: solution Route of administration: subcutaneous
Insulin glargine (HOE901) also known as Lantus Drug

Pharmaceutical form: solution Route of administration: subcutaneous
Metformin Drug

Pharmaceutical form: tablet Route of administration: oral

Main thing measured	Change in HbA1c
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03798080 ↗