RECRUITINGPhase 3INTERVENTIONAL

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

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of Dimethyl Fumarate in Preserving Islet β-Cell Function in Patients With Type 1 Diabetes Mellitus

About This Trial

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 or placebo 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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Subjects who provide written willing to sign a consent form. 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

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).

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).

Locations (1)

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

Nanjing, Jiangsu, China