deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02735044

Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus (EDITION JUNIOR)

6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected Once Daily in Children and Adolescents Age 6 - 17 Years With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period

Sponsor: Sanofi

Conditions Type 1 Diabetes Mellitus
Interventions Background therapy Insulin glargine (100 units /mL) Insulin glargine,300 U/mL
Updated 24 times since 2017 Last updated: Mar 15, 2022 Started: Apr 14, 2016 Primary completion: May 31, 2018 Completion: Dec 20, 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 1 Diabetes Mellitus, this trial is completed. The trial is conducted by Sanofi and has accumulated 24 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 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~May 2017 · 30 days · monthly snapshot~May 2017 – ~Jul 2017 · 2 months · monthly snapshot~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshot~Aug 2017 – ~Sep 2017 · 31 days · monthly snapshot~Sep 2017 – ~Oct 2017 · 30 days · monthly snapshot~Oct 2017 – ~Nov 2017 · 31 days · monthly snapshot~Nov 2017 – ~Dec 2017 · 30 days · monthly snapshot~Dec 2017 – ~Jan 2018 · 31 days · monthly snapshot~Jan 2018 – ~Feb 2018 · 31 days · monthly snapshot~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Jul 2019 · 5 months · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Jan 2021 · 17 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Apr 2022 · 4 months · monthly snapshot~Apr 2022 – ~Jul 2024 · 27 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

24 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. Apr 2022 — Jul 2024 [monthly]

    Completed PHASE3

  5. Dec 2021 — Apr 2022 [monthly]

    Completed PHASE3

▶ Show 19 earlier versions

  1. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE3

  2. Aug 2019 — Jan 2021 [monthly]

    Completed PHASE3

  3. Jul 2019 — Aug 2019 [monthly]

    Completed PHASE3

  4. Feb 2019 — Jul 2019 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  5. Jan 2019 — Feb 2019 [monthly]

    Active Not Recruiting PHASE3

  6. Jun 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE3

  7. Mar 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  8. Feb 2018 — Mar 2018 [monthly]

    Recruiting PHASE3

  9. Jan 2018 — Feb 2018 [monthly]

    Recruiting PHASE3

  10. Dec 2017 — Jan 2018 [monthly]

    Recruiting PHASE3

  11. Nov 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  12. Oct 2017 — Nov 2017 [monthly]

    Recruiting PHASE3

  13. Sep 2017 — Oct 2017 [monthly]

    Recruiting PHASE3

  14. Aug 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

  15. Jul 2017 — Aug 2017 [monthly]

    Recruiting PHASE3

  16. May 2017 — Jul 2017 [monthly]

    Recruiting PHASE3

  17. Apr 2017 — May 2017 [monthly]

    Recruiting PHASE3

  18. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE3

  19. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Apr 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

Atlanta, United States , Barcelona, Spain , Beersheba, Israel , Belgrade, Serbia , Bielsko-Biala, Poland , Bucharest, Romania , Budapest, Hungary , Buffalo, United States , Caba, Argentina , Capital Federal, Argentina and 83 more locations