Dimethyl fumarate to preserve insulin-producing beta cells in adults with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label, non-randomized, parallel-controlled Phase 2/3 trial comparing dimethyl fumarate plus standard insulin therapy to standard insulin alone in adults with type 1 diabetes. A total of 96 participants (32 receiving dimethyl fumarate, 64 controls) aged 18–65 who meet ADA 2024 criteria, have at least two positive islet autoantibodies, and a random C‑peptide ≥200 pmol/L will be enrolled. Dimethyl fumarate is started at 120 mg twice daily and increased after 7 days to 240 mg twice daily while safety, tolerability, and beta-cell function are monitored. Outcomes focus on preservation of C‑peptide and safety signals during the treatment period with scheduled clinic visits at the trial site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Willing and able to participate in the study and provide signed informed consent
* Aged 18 to 65 years
* Diagnosed with type 1 diabetes mellitus according to ADA 2024 criteria
* Positive for at least 2 islet autoantibodies among insulin autoantibody (IAA), glutamic acid decarboxylase autoantibody (GADA), insulinoma-associated protein 2 autoantibody (IA-2A), islet cell antibody (ICA), and zinc transporter 8 autoantibody (ZnT8A)
* Random C-peptide level greater than or equal to 200 pmol/L

Note:

\- For participants who have used insulin for more than 14 days, a positive IAA result must be accompanied by at least 2 additional positive autoantibodies other than IAA

Exclusion Criteria:

* Pregnant or breastfeeding women, positive urine pregnancy test at screening, or inability to rule out pregnancy in the opinion of the investigator
* Good glycemic control with oral antidiabetic drugs alone
* Participation in other studies involving diabetes treatment or immunomodulation
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal
* Patients with renal insufficiency or evidence of renal impairment:

eGFR \<60 mL/min/1.73 m²; or other renal diseases considered by the investigator to be unsuitable for study enrollment

* History of malignancy, uncontrolled immune system disease, or uncontrolled infection
* Alcohol abuse, drug abuse, psychiatric disorder, or other conditions considered unsuitable for participation in a drug trial
* Use of other immunosuppressive agents within 12 weeks before enrollment
* Participation in any other drug trial within 12 weeks before enrollment
* History of multiple drug allergies, allergic diseases, hypersensitivity constitution, or drug dependence
* Any disease or condition that, in the opinion of the investigator, may interfere with study participation or evaluation

Where it's running

• Jiangsu Provincial Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Yong Gu — Department of Endocrinology, Jiangsu Provincial Hospital
• Study coordinator: Yong Gu
• Email: yong.gu@njmu.edu.cn
• Phone: +86 13814084876

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VV-14300: a gene therapy approach for adults with type 1 diabetes not well controlled on an automated insulin system

  This trial tests VV-14300 in adults with type 1 diabetes who aren’t reaching their blood sugar goals despite using an automated insulin delivery system.

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• New gene therapies VV-14299 and VV-14300 for adults with Type 1 Diabetes failing automated insulin delivery

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  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Melbourne · NCT07829302

• Oral verapamil in newly diagnosed children and teens with type 1 diabetes

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• Near-sensor insulin delivery with CGM in people with type 1 diabetes

  A small early-feasibility study tests a dual-port insulin patch pump that includes a CGM sensor to see if delivering insulin near the sensor affects glucose readings and whether an automated control algorithm can manage glucose.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.