NCT07258394 Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus
| NCT ID | NCT07258394 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Nanjing Medical University |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-01-27 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 90 participants in total. It began in 2026-01-27 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Subjects who provide written informed consent. 2. Aged 18-65 years. 3. Diagnosed with Type 1 Diabetes Mellitus (per ADA 2024 criteria). 4. 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. 5. Disease duration ≤100 days post-T1DM diagnosis. 6. Random C-peptide ≥ 200 pmol/L. Exclusion Criteria: 1. Pregnancy, lactation, or women of childbearing potential not using contraception. 2. Well-controlled glycemia with oral hypoglycemic agents alone. 3. Participation in other diabetes/immune-modulating trials. 4. ALT/AST \>3× upper limit of normal (ULN). 5. History of malignancy, uncontrolled autoimmune disorders, or active infections. 6. Alcohol/drug abuse, psychiatric disorders, or conditions unsuitable for trial participation. 7. Use of immunosuppressants within 12 weeks prior. 8. Participation in other drug trials within 12 weeks prior. 9. History of drug allergies, hypersensitivity, or drug addiction. 10. Any condition deemed by investigators to compromise study integrity.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07258394 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07258394 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 90 participants.
Is NCT07258394 currently recruiting?
Yes, NCT07258394 is actively recruiting participants. Contact the research team at yong.gu@njmu.edu.cn for enrollment information.
Where is the NCT07258394 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07258394 clinical trial?
NCT07258394 is sponsored by Nanjing Medical University. The trial plans to enroll 90 participants.
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