Actively Recruiting
Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes
Led by Nanjing Medical University · Updated on 2026-04-23
96
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a non-randomized, parallel-controlled, single-center, open-label clinical trial designed to evaluate the efficacy of dimethyl fumarate in preserving pancreatic beta-cell function in adults with type 1 diabetes, as well as its safety and tolerability in this population. Eligible participants are adults aged 18 to 65 years who meet the ADA 2024 diagnostic criteria for type 1 diabetes, have at least 2 positive islet autoantibodies, and have residual beta-cell function as evidenced by a random C-peptide level of at least 200 pmol/L. A total of 96 participants are planned for enrollment, including 32 in the dimethyl fumarate treatment group and 64 in the standard-treatment control group. Participants in the treatment group will receive dimethyl fumarate enteric-coated capsules in addition to standard insulin therapy for type 1 diabetes. Dimethyl fumarate will be initiated at 120 mg twice daily and increased after 7 days to a maintenance dose of 240 mg twice daily. Participants in the control group will receive standard insulin therapy alone. The intervention period will be 24 weeks, followed by 52 weeks of follow-up. The primary efficacy endpoint is the baseline-adjusted geometric mean area under the serum C-peptide curve during a 2-hour mixed-meal tolerance test at Week 24. Secondary endpoints include measures of beta-cell function at multiple time points, changes in glycated hemoglobin, proportions of participants with good or poor glycemic control, insulin dose requirements, and immunologic markers including lymphocyte subsets, cytokine profiles, and islet autoantibody characteristics. Safety assessments will include the incidence of flushing, gastrointestinal adverse events, allergic reactions, opportunistic infections, liver function abnormalities, lymphopenia, renal abnormalities, hypoglycemia, severe hypoglycemia, ketosis, and ketoacidosis. The total study duration is 36 months, from January 2026 to December 2028.
CONDITIONS
Official Title
Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- For participants using insulin for more than 14 days, a positive IAA must be accompanied by at least 2 additional positive autoantibodies other than IAA
You will not qualify if you...
- Pregnant or breastfeeding women, positive urine pregnancy test at screening, or inability to rule out pregnancy
- 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 kidney damage, including eGFR less than 60 mL/min/1.73 m², urinary albumin-to-creatinine ratio greater than or equal to 3.4 mg/mmol, or other kidney disease unsuitable for enrollment
- History of malignancy, uncontrolled immune system disease, or uncontrolled infection
- Alcohol abuse, drug abuse, psychiatric disorder, or other unsuitable conditions for drug trials
- 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 may interfere with study participation or evaluation according to the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jiangsu Provincial Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
Y
Yong Gu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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