Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes

Sponsor
Nanjing Medical University
Study ID
NCT07548996
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Dimethyl Fumarate Enteric-coated Capsules — DRUG
    Dimethyl fumarate enteric-coated capsules, initiated at 120 mg twice daily and increased after 7 days to 240 mg twice daily.
  • Insulin — DRUG
    Standard insulin therapy for type 1 diabetes according to routine clinical practice.

Study Details

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.

Key Dates

First listed
Apr 23, 2026
Start date
Apr 27, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
96 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dimethyl Fumarate Plus Standard Insulin Therapy
    Participants in this arm 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 240 mg twice daily. The intervention period will last 24 weeks, followed by 52 weeks of follow-up.
  • Active Comparator: Standard Insulin Therapy
    Participants in this arm will receive standard insulin therapy for type 1 diabetes without dimethyl fumarate. Participants will be followed according to the study schedule for 24 weeks of treatment observation and 52 weeks of follow-up.

Primary Outcome Measure

Baseline-Adjusted Geometric Mean Area Under the Serum C-Peptide Curve During a 2-Hour Mixed-Meal Tolerance Test [ Time Frame: 24 weeks after end of intervention (48 weeks after enrollment) ]

Central Contacts

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