deltatrials
Terminated PHASE2 INTERVENTIONAL 2-arm NCT02387164

Prevention Trial: Immune-tolerance With Alum-GAD (Diamyd) and Vitamin D3 to Children With Multiple Islet Autoantibodies (DiAPREV-IT2)

Double-blind, Investigator-initiated Study to Determine the Effect of Alum-GAD (Diamyd) in Combination With Vitamin D3 on the Progression to Type 1 Diabetes in Children With Multiple Islet Autoantibodies

Sponsor: Lund University

Updated 12 times since 2017 Last updated: Oct 27, 2020 Started: Mar 9, 2015 Primary completion: Oct 7, 2019 Completion: Oct 7, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study was interrupted early and terminated when only 26 out of 80 patients were enrolled due to new clinical study results indicating that the current study would not be informative.

A PHASE2 clinical study on Diabetes Mellitus, Type 1 and Prediabetic State, this trial is terminated or withdrawn. The trial is conducted by Lund University and has accumulated 12 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Sep 2017 · 8 months · monthly snapshotEnrolling By Invitation~Sep 2017 – ~Jun 2018 · 9 months · monthly snapshotEnrolling By Invitation~Jun 2018 – ~Feb 2019 · 8 months · monthly snapshotEnrolling By Invitation~Feb 2019 – ~Sep 2020 · 19 months · monthly snapshotActive Not Recruiting~Sep 2020 – ~Nov 2020 · 2 months · monthly snapshotCompleted~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshotTerminated~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 10 months · monthly snapshotTerminated

Change History

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

    Terminated PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  4. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  5. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE2

Show 7 earlier versions
  1. Dec 2020 — Jan 2021 [monthly]

    Terminated PHASE2

  2. Nov 2020 — Dec 2020 [monthly]

    Terminated PHASE2

    Status: CompletedTerminated

  3. Sep 2020 — Nov 2020 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  4. Feb 2019 — Sep 2020 [monthly]

    Active Not Recruiting PHASE2

    Status: Enrolling By InvitationActive Not Recruiting

  5. Jun 2018 — Feb 2019 [monthly]

    Enrolling By Invitation PHASE2

  6. Sep 2017 — Jun 2018 [monthly]

    Enrolling By Invitation PHASE2

  7. Jan 2017 — Sep 2017 [monthly]

    Enrolling By Invitation PHASE2

    First recorded

Mar 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Lund University
  • Region Skane
Data source: Lund University

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

Study Locations