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

NCT02749890 · Completed

Last updated 2026-05-28

This clinical trial is testing a combination of two diabetes medications (insulin glargine and lixisenatide) compared to lixisenatide alone in adults with type 2 diabetes who are already taking oral anti-diabetic drugs in Japan.

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 321 people

Who can join Ages 20+ · all sexes

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

Where 61 sites · Japan

What this study is testing ClinicalTrials.gov NCT02749890 ↗

Description as written by the study sponsor.

Primary Objective: To compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus. Secondary Objective: To compare the overall efficacy and safety of LixiLan to lixisenatide (with or without OADs) over a 52 week treatment period 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
Lixisenatide (AVE0010) 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 NCT02749890 ↗