deltatrials
Terminated PHASE3 INTERVENTIONAL 4-arm NCT03713684

Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s) (AMPLITUDE-L)

A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)

Sponsor: Hanmi Pharmaceutical Company Limited

Updated 23 times since 2018 Last updated: Nov 4, 2021 Started: Nov 9, 2018 Primary completion: Nov 20, 2020 Completion: Jan 4, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Sponsor decision to cancel TRIAL, not related to safety concern

Listed as NCT03713684, this PHASE3 trial focuses on Type 2 Diabetes Mellitus and remains terminated or withdrawn. Sponsored by Hanmi Pharmaceutical Company Limited, it has been updated 23 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Apr 2019 · 4 months · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Sep 2019 · 3 months · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Feb 2020 · 4 months · monthly snapshot~Feb 2020 – ~Apr 2020 · 2 months · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Dec 2020 · 2 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Apr 2021 · 59 days · monthly snapshot~Apr 2021 – ~Jan 2022 · 9 months · monthly snapshot~Jan 2022 – ~Jul 2024 · 30 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

23 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  4. Jan 2022 — Jul 2024 [monthly]

    Terminated PHASE3

  5. Apr 2021 — Jan 2022 [monthly]

    Terminated PHASE3

Show 18 earlier versions
  1. Feb 2021 — Apr 2021 [monthly]

    Terminated PHASE3

    Status: Active Not RecruitingTerminated

  2. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE3

  3. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  4. Oct 2020 — Dec 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  5. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE3

  6. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE3

  7. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE3

  8. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE3

  9. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE3

  10. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE3

  11. Feb 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  12. Oct 2019 — Feb 2020 [monthly]

    Recruiting PHASE3

  13. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  14. Jun 2019 — Sep 2019 [monthly]

    Not Yet Recruiting PHASE3

  15. May 2019 — Jun 2019 [monthly]

    Not Yet Recruiting PHASE3

  16. Apr 2019 — May 2019 [monthly]

    Not Yet Recruiting PHASE3

  17. Dec 2018 — Apr 2019 [monthly]

    Not Yet Recruiting PHASE3

  18. Nov 2018 — Dec 2018 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hanmi Pharmaceutical Company Limited
  • Sanofi
Data source: Sanofi

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