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NCT Number: NCT07258394

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Nanjing, Jiangsu, 210029, China

Location status: Recruiting

Location contact

Yong Gu

CONTACT

[email protected]

+8613645148415

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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).

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).

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.

    Time frame: Post-intervention Weeks 24

    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.

Secondary outcomes

  1. 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.

    Time frame: Week 24 of intervention and 52 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.

  2. 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.

    Time frame: Intervention Week 24, and Post-intervention Weeks 24 and 52

    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.

  3. 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).

    Time frame: Post-intervention Week 52

    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.

  4. Glycemic Control Status

    Time frame: Intervention Week 24, and Post-intervention Weeks 24 and 52

    Hemoglobin A1c (HbA1c) levels and changes from baseline; Number of participants with poor glycemic control (HbA1c > 9%); Number of participants with good glycemic control (HbA1c < 6.5%).

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

    Time frame: Intervention Week 24, and Post-intervention Weeks 24 and 52

  6. Immunological markers

    Time frame: Baseline, Week 24 During Intervention, and 24,52 Weeks After Intervention

    Count, phenotype, and functional characteristics of white blood cell (WBC) subsets (including T cells, B cells, and natural killer [NK] cells); serum proinflammatory and regulatory cytokine profiles, along with other immune mediators; and the number of positive types, specific types, and titer levels of islet autoantibodies.

  7. Incidence Rates of Flushing, Abdominal Pain, Diarrhea, Nausea, Vomiting, Pruritus, Rash, Proteinuria, Erythema, and Dyspepsia

    Time frame: Week 4, 8, 12, 16, and 24 During Intervention

  8. Incidence Rates of Anaphylaxis, Angioedema, and Opportunistic Infections

    Time frame: Week 4, 8, 12, 16, and 24 During Intervention

  9. Incidence Rates of Elevated Aspartate Aminotransferase (AST), Elevated Total Bilirubin (TBIL), and Lymphocytopenia

    Time frame: Week 4, 8, 12, 16, and 24 During Intervention

  10. Incidence Rates of Hypoglycemia/Severe Hypoglycemia and Ketosis/Diabetic Ketoacidosis (DKA)

    Time frame: Baseline, Weeks4, 8, 12, 16, 20 and 24 During Intervention, and 12, 24, 36, and 52 Weeks After Intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Yong Gu

CONTACT

[email protected]

+86 13814084876

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 2, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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