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Phase 2/3Active, not recruitingNCT03941132

UST1D2: Ustekinumab phase-2/3 in adults with recent-onset T1D

What this study tests

Active phase-2/3 trial testing ustekinumab in adults with recent-onset T1D, following earlier pilot and adolescent signals.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2025-02-24.

Most recent recorded citation date: 2025-02-24. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Adults aged 18–35 within 100 days of T1D diagnosis, with at least one diabetes autoantibody and mixed-meal C-peptide above 0.2 nmol/L. Infection, immune-system and other exclusions apply. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
No results posted. Live-checked 27 August 2026: still active, not recruiting; last registry update 20 February 2025; estimated n=66; estimated primary completion 1 February 2026 has passed without posted results — that is not a result.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: Canada. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Change in two-hour mixed-meal C-peptide AUC at week 52.
  • Adverse-event frequency and severity through week 52.

The full picture

UST1D2 is an adult trial testing whether the C-peptide signal reported for ustekinumab in adolescents extends to adults with recent-onset T1D; the registry lists C-peptide change as a primary endpoint and posts no results.

Sources

  1. [1]