Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan

NCT02752828 · Completed

Last updated 2026-05-28

This clinical trial tested a combination of two diabetes medications (insulin glargine and lixisenatide) compared to insulin glargine alone in adults with type 2 diabetes who were already taking oral diabetes drugs.

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 521 people

Who can join Ages 20+ · all sexes

Timeline Started 2016-05 · est. completion 2018-03

Where 113 sites · Japan

What this study is testing ClinicalTrials.gov NCT02752828 ↗

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. Secondary Objective: To compare the overall efficacy and safety of LixiLan to insulin glargine (with or without OADs) over a 26 Week treatment period in patients with type 2 Diabetes.

Treatments tested

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

Pharmaceutical form: solution Route of administration: subcutaneous
Insulin glargine (HOE901) Drug

Pharmaceutical form: solution Route of administration: subcutaneous
Oral anti-diabetic drugs 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	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02752828 ↗