Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)

NCT03798054 · Completed

Last updated 2026-05-28

This clinical trial tested a combination of insulin glargine and lixisenatide in adults with type 2 diabetes whose blood sugar was not well controlled by oral diabetes medications.

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 878 people

Who can join Ages 18+ · all sexes

Timeline Started 2019-02 · est. completion 2021-03

Where 79 sites · China, Malaysia, South Korea, Taiwan

What this study is testing ClinicalTrials.gov NCT03798054 ↗

Description as written by the study sponsor.

Primary Objectives: The co-primary objective of this study is: * To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) versus lixisenatide on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change. * To demonstrate the non-inferiority of iGlarLixi versus insulin glargine on glycemic control as assessed by HbA1c change. Secondary Objectives: * To assess the effects of iGlarLixi in comparison with insulin glargine alone and lixisenatide alone. * 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
Lixisenatide (AVE0010) also known as Lyxumia Drug

Pharmaceutical form: solution Route of administration: subcutaneous
Metformin Drug

Pharmaceutical form: tablet Route of administration: oral
SGLT2 inhibitor 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 NCT03798054 ↗