NCT02752828 (LIXILAN JP-O2) is a Phase 3 clinical trial of Insulin glargine/lixisenatide (HOE901/AVE0010) in Type 2 Diabetes Mellitus, sponsored by Sanofi.

Who is sponsoring NCT02752828?

NCT02752828 is sponsored by Sanofi.

What drugs are being tested in NCT02752828?

Interventions in NCT02752828: Insulin glargine/lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), Oral anti-diabetic drugs.

What condition does NCT02752828 study?

NCT02752828 studies Type 2 Diabetes Mellitus.

Is NCT02752828 still recruiting?

NCT02752828 is currently completed. Last updated 16 June 2020.

Last reviewed 2020-06-16 · How we verify

NCT02752828: LIXILAN JP-O2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 16 June 2020

What this trial tests

Phase 3 trial testing Insulin glargine/lixisenatide (HOE901/AVE0010) in Type 2 Diabetes Mellitus in 521 participants. Completed in 12 March 2018.

Timeline

23 May 2016

Primary endpoint
12 March 2018

12 March 2018

Quick facts

Lead sponsor	Sanofi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	521
Start date	23 May 2016
Primary completion	12 March 2018
Estimated completion	12 March 2018
Sites	113 locations across Japan

Drugs / interventions tested

Insulin glargine/lixisenatide (HOE901/AVE0010) — full drug profile →
Insulin glargine (HOE901) — full drug profile →
Oral anti-diabetic drugs — full drug profile →

Conditions studied

Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Sanofi — full company profile →

Who can join

20 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi 1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26-week, open-label, multicentre study: The LixiLan JP-O2 randomized c
Terauchi Y, Nakama T, Spranger R, Amano A, et al · · 2020 · cited 33× · PMID 32291880 · DOI 10.1111/dom.14036
Benefits of the fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide (iGlarLixi) in Japanese people with type 2 diabetes: A subgroup and time-to-control analysis of the LixiLan JP phase 3 trials.
Terauchi Y, Yabe D, Kaneto H, Amano A, et al · · 2020 · cited 6× · PMID 33404200 · DOI 10.1111/dom.14139
Benefit of insulin glargine/lixisenatide for reducing residual hyperglycaemia in Japan: Post hoc analysis of the LixiLan JP-O2 trial.
Iizuka K, Baxter M, Watanabe D, Yabe D. · · 2021 · cited 3× · PMID 34472693 · DOI 10.1111/dom.14537

Verify or expand the search:

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02752828 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 16 June 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02752828.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing