Dimethyl fumarate to preserve insulin-producing beta cells in adults with type 1 diabetes
Non-Randomized, Parallel-Controlled, Single-Center, Open-Label Clinical Trial Evaluating the Efficacy and Safety of Dimethyl Fumarate in Preserving Pancreatic β-Cell Function in Adults With Type 1 Diabetes
This study will try adding dimethyl fumarate to insulin to see if it helps preserve beta-cell function in adults 18–65 with type 1 diabetes who still make some insulin.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07548996 on ClinicalTrials.gov |
What this trial studies
This is a single-center, open-label, non-randomized, parallel-controlled Phase 2/3 trial comparing dimethyl fumarate plus standard insulin therapy to standard insulin alone in adults with type 1 diabetes. A total of 96 participants (32 receiving dimethyl fumarate, 64 controls) aged 18–65 who meet ADA 2024 criteria, have at least two positive islet autoantibodies, and a random C‑peptide ≥200 pmol/L will be enrolled. Dimethyl fumarate is started at 120 mg twice daily and increased after 7 days to 240 mg twice daily while safety, tolerability, and beta-cell function are monitored. Outcomes focus on preservation of C‑peptide and safety signals during the treatment period with scheduled clinic visits at the trial site.
Who should consider this trial
Good fit: Ideal candidates are adults 18–65 with type 1 diabetes per ADA 2024 who have at least two positive islet autoantibodies and a random C‑peptide of ≥200 pmol/L.
Not a fit: Patients without measurable residual beta-cell function (random C‑peptide <200 pmol/L), pregnant or breastfeeding individuals, or those unable to attend the single Nanjing site are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the treatment could slow loss of insulin-producing beta cells and potentially reduce insulin needs or improve blood-glucose stability.
How similar studies have performed: Dimethyl fumarate is effective in multiple sclerosis and psoriasis and shows beta-cell protective effects in preclinical work, but it has limited prior testing in human type 1 diabetes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willing and able to participate in the study and provide signed informed consent * Aged 18 to 65 years * Diagnosed with type 1 diabetes mellitus according to ADA 2024 criteria * Positive for at least 2 islet autoantibodies among insulin autoantibody (IAA), glutamic acid decarboxylase autoantibody (GADA), insulinoma-associated protein 2 autoantibody (IA-2A), islet cell antibody (ICA), and zinc transporter 8 autoantibody (ZnT8A) * Random C-peptide level greater than or equal to 200 pmol/L Note: \- For participants who have used insulin for more than 14 days, a positive IAA result must be accompanied by at least 2 additional positive autoantibodies other than IAA Exclusion Criteria: * Pregnant or breastfeeding women, positive urine pregnancy test at screening, or inability to rule out pregnancy in the opinion of the investigator * Good glycemic control with oral antidiabetic drugs alone * Participation in other studies involving diabetes treatment or immunomodulation * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal * Renal insufficiency or evidence of kidney damage, including estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m², urinary albumin-to-creatinine ratio (UACR) greater than or equal to 3.4 mg/mmol (repeat confirmation if necessary), or other kidney disease considered unsuitable for enrollment by the investigator * History of malignancy, uncontrolled immune system disease, or uncontrolled infection * Alcohol abuse, drug abuse, psychiatric disorder, or other conditions considered unsuitable for participation in a drug trial * Use of other immunosuppressive agents within 12 weeks before enrollment * Participation in any other drug trial within 12 weeks before enrollment * History of multiple drug allergies, allergic diseases, hypersensitivity constitution, or drug dependence * Any disease or condition that, in the opinion of the investigator, may interfere with study participation or evaluation
Where this trial is running
Nanjing, Jiangsu
- Jiangsu Provincial Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Yong Gu — Department of Endocrinology, Jiangsu Provincial Hospital
- Study coordinator: Yong Gu
- Email: yong.gu@njmu.edu.cn
- Phone: +86 13814084876
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.