deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02752828

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 (LIXILAN JP-O2)

A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Combination to Insulin Glargine on Top of OADs in Japanese Patients With Type 2 Diabetes Mellitus (T2DM)

Sponsor: Sanofi

Conditions Type 2 Diabetes Mellitus
Interventions Insulin glargine (HOE901) Insulin glargine/lixisenatide (HOE901/AVE0010) Oral anti-diabetic drugs
Updated 15 times since 2017 Last updated: Jun 11, 2020 Started: May 23, 2016 Primary completion: Mar 12, 2018 Completion: Mar 12, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Type 2 Diabetes Mellitus, this trial is completed. The trial is conducted by Sanofi and has accumulated 15 data snapshots since 2016. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~May 2017 · 2 months · monthly snapshot~May 2017 – ~Jun 2017 · 31 days · monthly snapshot~Jun 2017 – ~Jul 2017 · 30 days · monthly snapshot~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshot~Aug 2017 – ~Dec 2017 · 4 months · monthly snapshot~Dec 2017 – ~Apr 2018 · 4 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Jul 2020 · 25 months · monthly snapshot~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 9 months · monthly snapshot

Change History

15 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jul 2020 — Jan 2021 [monthly]

    Completed PHASE3

▶ Show 10 earlier versions

  1. Jun 2018 — Jul 2020 [monthly]

    Completed PHASE3

  2. Apr 2018 — Jun 2018 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  3. Dec 2017 — Apr 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  4. Aug 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  5. Jul 2017 — Aug 2017 [monthly]

    Recruiting PHASE3

  6. Jun 2017 — Jul 2017 [monthly]

    Recruiting PHASE3

  7. May 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  8. Mar 2017 — May 2017 [monthly]

    Recruiting PHASE3

  9. Feb 2017 — Mar 2017 [monthly]

    Recruiting PHASE3

  10. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

May 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Sanofi
Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Adachi-Ku, Japan , Annaka-Shi, Japan , Arakawa-Ku, Japan , Atsugi-Shi, Japan , Chiba, Japan , Chigasaki-Shi, Japan , Chiyoda-Ku, Japan , Chūōku, Japan , Fujimi-Shi, Japan , Fujisawa-Shi, Japan and 74 more locations