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

NCT ID: NCT07258394

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-12-31

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 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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dimethyl fumarate Arm

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).

Group Type: EXPERIMENTAL

Dimethyl Fumarate Enteric-coated Capsules

Intervention Type: DRUG

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).

Placebo Arm

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).

Group Type: PLACEBO_COMPARATOR

Matching placebo capsules

Intervention Type: DRUG

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).

Interventions

Dimethyl Fumarate Enteric-coated Capsules

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).

Intervention Type: DRUG

Matching placebo capsules

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).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Qilu Pharmaceutical (Hainan) Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yong Gu

Deputy Director of Endocrinology Dept.; Associate Chief Physician; Associate Professor; Principal Investigator, The First Affiliated Hospital with Nanjing Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Deparement of Endocrinology and Metabolism, The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Yong Gu

Role: CONTACT

yong.gu@njmu.edu.cn

+86 13814084876

Other Identifiers

2025-SR-439

Identifier Type: -

Identifier Source: org_study_id