BridgeMD
New treatment option for Type 1 Diabetes Mellitus
Official title Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes
ClinicalTrials.gov ID: NCT07548996
What this study is testing
What is Dimethyl Fumarate Enteric-coated Capsules?
Dimethyl Fumarate Enteric-coated Capsules is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for type 1 diabetes mellitus.
Also referred to as DMF.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a non-randomized, parallel-controlled, single-center, open-label clinical trial designed to evaluate the efficacy of dimethyl fumarate in preserving pancreatic beta-cell function in adults with type 1 diabetes, as well as its safety and tolerability in this population. Eligible participants are adults aged 18 to 65 years who meet the ADA 2024 diagnostic criteria for type 1 diabetes, have at least 2 positive islet autoantibodies, and have residual beta-cell function as evidenced by a random C-peptide level of at least 200 pmol/L.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- History of malignancy, uncontrolled immune system disease, or uncontrolled infection
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.