Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs

NCT02752412 · Completed

Last updated 2026-05-28

This clinical trial tested a combination treatment (LixiLan) compared to insulin glargine alone, both with metformin, in Japanese adults with type 2 diabetes whose blood sugar was not well controlled by basal insulin and other 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 513 people

Who can join Ages 20+ · all sexes

Timeline Started 2016-05 · est. completion 2018-10

Where 122 sites · Japan

What this study is testing ClinicalTrials.gov NCT02752412 ↗

Description as written by the study sponsor.

Primary Objective: To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to week 26 in patients with type 2 diabetes mellitus. Secondary Objective: To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in patients with type 2 diabetes mellitus.

Treatments tested

Insulin glargine/Lixisenatide (HOE901/AVE0010) also known as LixiLan Drug

Pharmaceutical form: solution Route of administration: subcutaneous
Insulin glargine U100 (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 from baseline in HbA1c
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02752412 ↗