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

NCT07258394 | Recruiting Phase 3 DMC

• 1 other identifier: 2025-SR-439
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Immunotherapy; Pancreatic Beta-Cell Function

Outcome Measures

Primary Outcomes (1)

• Baseline-adjusted geometric mean area under the serum C-peptide curve (C-peptide AUC) during a 2-hour mixed-meal tolerance test (MMTT) 24 weeks post-intervention.

  Participants will consume a standardized liquid meal containing fixed amounts of carbohydrate, fat, and protein. Following consumption, blood glucose, C-peptide, and glucagon levels will be measured at 0-, 30-, 60-, 90-, and 120-minute time points over a 2-hour period.

  Post-intervention Weeks 24

Secondary Outcomes (10)

• Baseline-adjusted geometric mean area under the curve (AUC) for serum C-peptide during a 2-hour mixed-meal tolerance test (MMTT) at 24 weeks of intervention and 52 weeks after the end of intervention.

  Week 24 of intervention and 52 weeks post-intervention

• Changes from baseline in the geometric mean area under the C-peptide curve (AUC-C-peptide) during the 2-hour Mixed-Meal Tolerance Test (MMTT) at Intervention Week 24 and at Weeks 24 and 52 after the end of the intervention.

  Intervention Week 24, and Post-intervention Weeks 24 and 52

• The number of subjects who remained C-peptide positive at 52 weeks after the end of intervention (defined as a stimulated peak serum C-peptide concentration >= 200 pmol/L during a 2-hour MMTT).

  Post-intervention Week 52

• Glycemic Control Status

  Intervention Week 24, and Post-intervention Weeks 24 and 52

• Mean Daily Dose of Exogenous Insulin Used During the 7 Days Preceding Each Study Visit

  Intervention Week 24, and Post-intervention Weeks 24 and 52

Study Arms (2)

Dimethyl fumarate Arm

EXPERIMENTAL

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: Dimethyl Fumarate Enteric-coated Capsules

Placebo Arm

PLACEBO COMPARATOR

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).

Drug: Matching placebo capsules

Interventions

Dimethyl Fumarate Enteric-coated Capsules 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).

Dimethyl fumarate Arm

Matching placebo capsules 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).

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who provide written informed consent.
• Aged 18-65 years.
• Diagnosed with Type 1 Diabetes Mellitus (per ADA 2024 criteria).
• 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.
• Disease duration ≤100 days post-T1DM diagnosis.
• Random C-peptide ≥ 200 pmol/L.

You may not qualify if:

• Pregnancy, lactation, or women of childbearing potential not using contraception.
• Well-controlled glycemia with oral hypoglycemic agents alone.
• Participation in other diabetes/immune-modulating trials.
• ALT/AST \>3× upper limit of normal (ULN).
• History of malignancy, uncontrolled autoimmune disorders, or active infections.
• Alcohol/drug abuse, psychiatric disorders, or conditions unsuitable for trial participation.
• Use of immunosuppressants within 12 weeks prior.
• Participation in other drug trials within 12 weeks prior.
• History of drug allergies, hypersensitivity, or drug addiction.
• Any condition deemed by investigators to compromise study integrity.

Sponsors & Collaborators

• Nanjing Medical University: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Qilu Pharmaceutical (Hainan) Co., Ltd.: collaborator

Study Sites (1)

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

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Yong Gu

CONTACT

+86 13814084876; yong.gu@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Endocrinology Dept.; Associate Chief Physician; Associate Professor; Principal Investigator, The First Affiliated Hospital with Nanjing Medical University

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: December 2, 2025
• Study Start: January 27, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)