USTEKID: Ustekinumab in adolescents with recent-onset type 1 diabetes
What this study tests
Multicenter double-blind randomized phase-2 trial of ustekinumab in adolescents with recent-onset T1D. It met its 12-month C-peptide endpoint with no increase in adverse events.
Editorial review: .
Most recent recorded citation date: 2025-09-01. 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
Evidence at a glance
- Who can enter the study?
- Adolescents aged 12–18 within 100 days of T1D diagnosis, with residual stimulated C-peptide meeting the trial threshold. See the protocol for other eligibility and safety criteria. 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
- The original Nature Medicine report randomized 72 adolescents. Its prespecified primary analysis had complete baseline and week-52 data for 62 participants; this smaller denominator is not a separate trial. At 12 months, stimulated C-peptide was 49% higher with ustekinumab (geometric mean ratio 1.49; 95% CI 1.08 to 2.06; P=0.02). Adverse-event rates did not increase. The ISRCTN record was last updated 1 September 2025 and lists a study end of 31 October 2022. Its final-enrollment field is 88, which must not be substituted for the paper’s 72 randomized or 62 in the primary analysis.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: United Kingdom. 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
- Stimulated C-peptide at 12 months
The full picture
The trial met its prespecified stimulated C-peptide endpoint at 52 weeks. The associated Th17.1-cell findings were exploratory and require replication; they do not establish a cure or routine clinical benefit for everyone with T1D.1
Sources
- [1]Ustekinumab for type 1 diabetes in adolescents · Peer-reviewed study · 2024-07-30
Tatovic D, et al. Ustekinumab for type 1 diabetes in adolescents. Nature Medicine (2024): primary outcome, exploratory immune findings and study limitations.
- [2]ISRCTN14274380: Ustekinumab in adolescents with recent-onset type 1 diabetes · Trial registry · 2025-09-01 — Last edited 1 September 2025; no longer recruiting; completed.