Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03941132 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Clinical Phase II/III Trial of Ustekinumab to Treat Type 1 Diabetes (UST1D2)

Study acronym: UST1D2
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 24, 2025 (before its estimated February 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: May 2026 to Feb 1, 2026
    • Study completion date: Nov 2026 to Nov 1, 2026
    • Site details revised at 2 of 2 sites
    v7
  2. Primary completion date: Jan 2024 to May 2026
    • Study completion date: Aug 2025 to Nov 2026
    v6
  3. Eligibility criteria revised
    • Study description revised
    v5
  4. Site details revised at 1 of 2 sitesv4
  5. Study sites: 1 to 2v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Dec 2022 to Jan 2024
    • Start date changed from estimate of Jul 2019 to Jan 4, 2021
    • Study completion date: Aug 2023 to Aug 2025
    • Site details revised
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In type 1 diabetes (T1D), immune defense cells in the body attack and destroy insulin-producing beta cells leaving affected people with a lifelong need for daily insulin injections. Even with insulin injections, blood glucose (sugar) control is imperfect and leads to many health complications and a shortened life span. Our pilot study (NCT02117765) has informed us that Ustekinumab is safe in the treatment of participants with recent-onset T1D. Ustekinumab is currently licensed for use in psoriasis where it has proven to be both highly effective and safe. The investigators hope that if the drug can block immune cells soon after the development of diabetes, any remaining insulin-producing cells may be protected, and regenerate, thus producing more insulin so that individuals may be insulin free, or require less insulin. This trial will assess the efficacy of Ustekinumab in decreasing C-peptide decline (proxy for endogenous insulin production) in participants with recent onset T1D.
Trial Details
NCT Number NCT03941132
Lead Sponsor University of British Columbia
Collaborators: Juvenile Diabetes Research Foundation, Janssen, LP
Conditions
(from sponsor)		 Type 1 Diabetes Mellitus
Related terms Diabetes Mellitus, Diabetes Mellitus, Type 1
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov