NCT07258394RecruitingPhase 3
Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus
A Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of Dimethyl Fumarate in Preserving Islet β-Cell Function in Patients With Type 1 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
Purpose of the Clinical Trial: This clinical trial aims to investigate whether dimethyl fumarate can treat adults with newly diagnosed type 1 diabetes and to evaluate the safety profile of dimethyl fumarate. Primary Research Questions: Does dimethyl fumarate protect pancreatic beta-cell function in adults with newly diagnosed type 1 diabetes? What medical issues may arise in individuals taking dimethyl fumarate? Study Design: Researchers will compare dimethyl fumarate with a placebo (an identical substance without active ingredients) to determine whether Dimethyl fumarate can effectively treat type 1 diabetes. Participant Activities: Take dimethyl fumarate or placebo orally twice daily for 24 weeks. Attend on-site visits every 4 weeks during the intervention period and every 12 weeks after the intervention for examinations and assessments. Record symptoms, blood glucose control, islet function, and insulin usage throughout the trial.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 28 Jul 2025
- Start date
- 27 Jan 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Nanjing Medical University
- Diseases
- Type 1 diabetes
- NCT number
- NCT07258394
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 90
- From 27 Jan 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of immunosuppressants within 12 weeks prior.
- Participation in other drug trials within 12 weeks prior.
Other illness
- Participation in other diabetes/immune-modulating trials.
- History of malignancy, uncontrolled autoimmune disorders, or active infections.
- Alcohol/drug abuse, psychiatric disorders, or conditions unsuitable for trial participation.
- History of drug allergies, hypersensitivity, or drug addiction.
- Any condition deemed by investigators to compromise study integrity.
Lab values
- ALT/AST \>3× upper limit of normal (ULN).
Other
- Pregnancy, lactation, or women of childbearing potential not using contraception.
- Well-controlled glycemia with oral hypoglycemic agents alone.
Who the study is looking for
- Subjects who provide written informed consent.
- Aged 18-65 years.
- Diagnosed with Type 1 Diabetes Mellitus (per ADA 2024 criteria).
- Positive for ≥2 autoantibodies: Insulin autoantibody (IAA) Glutamic acid decarboxylase autoantibody (GADA) Protein tyrosine phosphatase antibody (IA-2A) Islet cell antibody (ICA) Zinc transporter 8 autoantibody (ZnT8A) Note: For IAA-positive subjects with insulin use \>14 days, ≥2 additional autoantibodies must be positive.
- Disease duration ≤100 days post-T1DM diagnosis.
- Random C-peptide ≥ 200 pmol/L.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Deparement of Endocrinology and Metabolism, The First Affiliated Hospital with Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.