Open-label dimethyl fumarate plus insulin in adults with T1D
What this study tests
Recruiting Chinese phase 2/3 study comparing dimethyl fumarate plus standard insulin with standard insulin alone in 96 adults with residual beta-cell function. It is nonrandomized and open-label, so it is distinct from the separate randomized phase 3 study and more vulnerable to allocation bias.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-07-21.
Most recent recorded citation date: 2026-04-23. 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?
- Adults aged 18-65 with type 1 diabetes, at least two positive islet autoantibodies and random C-peptide of at least 200 pmol/L, subject to the registry's other clinical and renal eligibility 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
- No results posted. The study began on 27 April 2026 and is recruiting at Jiangsu Provincial Hospital in Nanjing, with primary and final completion estimated for 31 December 2028.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: Other regions. 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
- Baseline-adjusted geometric mean area under the serum C-peptide curve during a 2-hour mixed-meal tolerance test at week 48
The full picture
This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.
Sources
- [1]Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes · Trial registry · 2026-04-23 — Revision posted 21 July 2026 confirms recruiting status and an actual 27 April 2026 start. Design is nonrandomized, open-label and parallel with standard insulin as the active comparator.