Study Comparing the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM)

NCT03767543 · Completed

Last updated 2026-05-28

This clinical trial tested a combination of two diabetes medications, insulin glargine and lixisenatide, in adults with type 2 diabetes to see how it affects blood sugar levels over time.

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 265 people

Who can join Ages 18+ · all sexes

Timeline Started 2019-03 · est. completion 2020-10

Where 32 sites · Canada

What this study is testing ClinicalTrials.gov NCT03767543 ↗

Description as written by the study sponsor.

Primary Objective: To demonstrate that the simple daily titration algorithm is non-inferior to the weekly titration algorithm according to Canadian labeling. Secondary Objective: To gain additional information on the efficacy and safety of using a simple patient-titration protocol for administration of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi).

Treatments tested

INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010 Drug

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Main thing measured	Change in glycated hemoglobin (HbA1c)%
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03767543 ↗