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NCT02752412: LIXILAN JP-L
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
Phase 3 trial testing Insulin glargine/Lixisenatide (HOE901/AVE0010) in Type 2 Diabetes Mellitus in 513 participants. Completed in 4 October 2018.
4 October 2018
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 513 |
| Start date | 17 May 2016 |
| Primary completion | 4 October 2018 |
| Estimated completion | 4 October 2018 |
| Sites | 122 locations across Japan |
Drugs / interventions tested
- Insulin glargine/Lixisenatide (HOE901/AVE0010) — full drug profile →
- Insulin glargine U100 (HOE901) — full drug profile →
- Metformin (metformin) — 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 mellitus. Secondary Objective: To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in patients with type 2 diabetes mellitus.
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) in Japanese patients with type 2 diabetes mellitus inadequately controlled on basal insulin and oral antidiabetic drugs: The LixiLan JP-L randomized clinical trial.
Kaneto H, Takami A, Spranger R, Amano A, et al · · 2020 · cited 31× · PMID 32072742 · DOI 10.1111/dom.14005 -
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 -
iGlarLixi reduces residual hyperglycemia in Japanese patients with type 2 diabetes uncontrolled on basal insulin: A post-hoc analysis of the LixiLan JP-L trial.
Yabe D, Iizuka K, Baxter M, Watanabe D, et al · · 2021 · cited 5× · PMID 33945227 · DOI 10.1111/jdi.13563
Verify or expand the search:
- PubMed search for NCT02752412
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Insulin glargine/Lixisenatide (HOE901/AVE0010)
Trials testing the same drug.
- NCT03798080 — Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Pa · Phase 3 · completed
- NCT03798054 — Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Cont · Phase 3 · completed
Other recruiting trials for Type 2 Diabetes Mellitus
Currently open trials in the same condition.
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Other Sanofi trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02752412 (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/NCT02752412.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing