RecruitingPhase 3NCT07258394

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

Sponsor

Nanjing Medical University

Enrollment

90 participants

Start Date

Jan 27, 2026

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

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 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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called dimethyl fumarate — already used for other autoimmune conditions — can protect the insulin-producing cells of the pancreas in people who were recently diagnosed with type 1 diabetes, potentially slowing the progression of the disease. **You may be eligible if...** - You are 18 to 65 years old - You were recently diagnosed with type 1 diabetes (within the last 100 days) - You still have some insulin-producing ability (C-peptide level ≥ 200 pmol/L) - You test positive for at least 2 diabetes-related autoantibodies **You may NOT be eligible if...** - You are pregnant, breastfeeding, or not using contraception - You have significant liver problems - You have a history of cancer, uncontrolled autoimmune disease, or active infections - You have used immunosuppressive medications recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDimethyl 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).

DRUGMatching 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

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NCT07258394

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