Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus

Nanjing Medical University

Status and phase: Not yet enrolling; Phase 3

Conditions: Type 1 Diabetes

Treatments: Drug: Matching placebo capsules; Drug: Dimethyl Fumarate Enteric-coated Capsules

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07258394

2025-SR-439

Details and patient eligibility

About

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 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Dimethyl fumarate Arm

Experimental group

Description:

The dosing regimen for Dimethyl fumarate enteric-coated capsules initiates at 120 mg twice daily (bid). After 7 days, the dose should be escalated to the maintenance level of 240 mg bid. This investigational product is administered concurrently with standard insulin therapy for glycemic control in Type 1 Diabetes Mellitus (T1DM).

Treatment:

Drug: Dimethyl Fumarate Enteric-coated Capsules

Placebo Arm

Placebo Comparator group

Description:

The placebo capsules initiate at a dosage of 120 mg twice daily (bid). After 7 days, the dose should be increased to the maintenance level of 240 mg bid, administered concomitantly with standard insulin-based antihyperglycemic therapy for Type 1 Diabetes Mellitus (T1DM).

Treatment:

Drug: Matching placebo capsules