A Phase 2/3 interventional study of Dimethyl Fumarate Enteric-coated Capsules and Insulin in Type 1 Diabetes Mellitus, sponsored by Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Nanjing Medical University · Phase 2/3, Interventional, and Treatment
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. A total of 96 participants are planned for enrollment, including 32 in the dimethyl fumarate treatment group and 64 in the standard-treatment control group.
Participants in the treatment group will receive dimethyl fumarate enteric-coated capsules in addition to standard insulin therapy for type 1 diabetes. Dimethyl fumarate will be initiated at 120 mg twice daily and increased after 7 days to a maintenance dose of 240 mg twice daily. Participants in the control group will receive standard insulin therapy alone. The intervention period will be 24 weeks, followed by 52 weeks of follow-up.
The primary efficacy endpoint is the baseline-adjusted geometric mean area under the serum C-peptide curve during a 2-hour mixed-meal tolerance test at Week 24. Secondary endpoints include measures of beta-cell function at multiple time points, changes in glycated hemoglobin, proportions of participants with good or poor glycemic control, insulin dose requirements, and immunologic markers including lymphocyte subsets, cytokine profiles, and islet autoantibody characteristics. Safety assessments will include the incidence of flushing, gastrointestinal adverse events, allergic reactions, opportunistic infections, liver function abnormalities, lymphopenia, renal abnormalities, hypoglycemia, severe hypoglycemia, ketosis, and ketoacidosis.
The total study duration is 36 months, from January 2026 to December 2028.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 96 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Nanjing Medical University is the lead sponsor of 171 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
\<60 mL/min/1.73 m²; or other renal diseases considered by the investigator to be unsuitable for study enrollment
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive dimethyl fumarate enteric-coated capsules in addition to standard insulin therapy for type 1 diabetes. Dimethyl fumarate will be initiated at 120 mg twice daily and increased after 7 days to 240 mg twice daily. The intervention period will last 24 weeks, followed by 52 weeks of follow-up.
Drug: Dimethyl Fumarate Enteric-coated Capsules · Drug: Insulin
Participants in this arm will receive standard insulin therapy for type 1 diabetes without dimethyl fumarate. Participants will be followed according to the study schedule for 24 weeks of treatment observation and 52 weeks of follow-up.
Drug: Insulin
Dimethyl fumarate enteric-coated capsules, initiated at 120 mg twice daily and increased after 7 days to 240 mg twice daily.
Also known as: DMF
Standard insulin therapy for type 1 diabetes according to routine clinical practice.
Baseline-Adjusted Geometric Mean Area Under the Serum C-Peptide Curve During a 2-Hour Mixed-Meal Tolerance Test
The primary efficacy endpoint is the baseline-adjusted geometric mean area under the serum C-peptide curve during a 2-hour mixed-meal tolerance test (MMTT).
Time frame: 24 weeks after end of intervention (48 weeks after enrollment)
Baseline-Adjusted Geometric Mean Area Under the Serum C-Peptide Curve During a 2-Hour Mixed-Meal Tolerance Test
Baseline-adjusted geometric mean area under the serum C-peptide curve during a 2-hour mixed-meal tolerance test (MMTT).
Time frame: End of intervention (24 weeks after enrollment) and 52 weeks after end of intervention (76 weeks after enrollment)
Change From Baseline in Geometric Mean Area Under the Serum C-Peptide Curve During a 2-Hour Mixed-Meal Tolerance Test
Change from baseline in the geometric mean area under the serum C-peptide curve during a 2-hour mixed-meal tolerance test (MMTT).
Time frame: End of intervention (24 weeks after enrollment), 24 weeks after end of intervention (48 weeks after enrollment), and 52 weeks after end of intervention (76 weeks after enrollment)
Number of Participants Maintaining Positive C-Peptide Response After a 2-Hour Mixed-Meal Tolerance Test
Number of participants maintaining positive C-peptide response at 52 weeks after end of intervention, defined as a peak C-peptide concentration of at least 200 pmol/L after a 2-hour mixed-meal tolerance test (MMTT).
Time frame: 52 weeks after end of intervention (76 weeks after enrollment)
Glycated Hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c) level and change from baseline.
Time frame: End of intervention (24 weeks after enrollment), 24 weeks after end of intervention (48 weeks after enrollment), and 52 weeks after end of intervention (76 weeks after enrollment)
Number of Participants With Poor Glycemic Control
Number of participants with poor glycemic control, defined as HbA1c greater than 9%.
Time frame: End of intervention (24 weeks after enrollment), 24 weeks after end of intervention (48 weeks after enrollment), and 52 weeks after end of intervention (76 weeks after enrollment)
Number of Participants With Good Glycemic Control
Number of participants with good glycemic control, defined as HbA1c less than 6.5%.
Time frame: End of intervention (24 weeks after enrollment), 24 weeks after end of intervention (48 weeks after enrollment), and 52 weeks after end of intervention (76 weeks after enrollment)
Average Exogenous Insulin Dose
Average dose of exogenous insulin during the 7 days prior to each study visit, expressed as IU/kg/day.
Time frame: End of intervention (24 weeks after enrollment), 24 weeks after end of intervention (48 weeks after enrollment), and 52 weeks after end of intervention (76 weeks after enrollment)
Change from baseline in proportion of peripheral blood CD4+ T cells
Measured by flow cytometry and reported as percentage of lymphocytes.
Time frame: End of intervention (24 weeks after enrollment), 24 weeks after end of intervention (48 weeks after enrollment), and 52 weeks after end of intervention (76 weeks after enrollment)
Change from baseline in proportion of peripheral blood B cells
Measured by flow cytometry and reported as percentage of lymphocytes.
Time frame: End of intervention (24 weeks after enrollment), 24 weeks after end of intervention (48 weeks after enrollment), and 52 weeks after end of intervention (76 weeks after enrollment)
Change from baseline in proportion of peripheral blood natural killer cells
Measured by flow cytometry and reported as percentage of lymphocytes.
Time frame: End of intervention (24 weeks after enrollment), 24 weeks after end of intervention (48 weeks after enrollment), and 52 weeks after end of intervention (76 weeks after enrollment)
Change from baseline in proportion of peripheral blood regulatory T cells
Measured by flow cytometry and reported as percentage of lymphocytes.
Time frame: End of intervention (24 weeks after enrollment), 24 weeks after end of intervention (48 weeks after enrollment), and 52 weeks after end of intervention (76 weeks after enrollment)
Change from baseline in serum interleukin-6 concentration
Measured in serum
Time frame: End of intervention (24 weeks after enrollment), 24 weeks after end of intervention (48 weeks after enrollment), and 52 weeks after end of intervention (76 weeks after enrollment)
Change from baseline in serum tumor necrosis factor-alpha concentration
Measured in serum
Time frame: End of intervention (24 weeks after enrollment), 24 weeks after end of intervention (48 weeks after enrollment), and 52 weeks after end of intervention (76 weeks after enrollment)
Change from baseline in number of positive islet autoantibodies
Count of positive islet autoantibodies among GADA, IA-2A, ZnT8A, ICA, and IAA, reported as an integer from 0 to 5.
Time frame: End of intervention (24 weeks after enrollment), 24 weeks after end of intervention (48 weeks after enrollment), and 52 weeks after end of intervention (76 weeks after enrollment)
Change from baseline in glutamic acid decarboxylase autoantibody titer
Measured using an assay-specific method and reported in assay-specific units.
Time frame: End of intervention (24 weeks after enrollment), 24 weeks after end of intervention (48 weeks after enrollment), and 52 weeks after end of intervention (76 weeks after enrollment)
Change from baseline in zinc transporter 8 autoantibody titer
Measured using an assay-specific method and reported in assay-specific units.
Time frame: End of intervention (24 weeks after enrollment), 24 weeks after end of intervention (48 weeks after enrollment), and 52 weeks after end of intervention (76 weeks after enrollment)
Number of participants with composite treatment-related symptomatic adverse reactions
Participants with at least one occurrence of any of the following treatment-related symptomatic adverse reactions during the safety follow-up period: flushing, abdominal pain, diarrhea, nausea, vomiting, pruritus, rash, erythema, or dyspepsia.
Time frame: From first dose to 52 weeks after end of intervention (up to 76 weeks after enrollment)
Number of participants with composite hypersensitivity or opportunistic infection events
Participants with at least one occurrence of any of the following during the safety follow-up period: immediate hypersensitivity reaction, angioedema, or opportunistic infection.
Time frame: From first dose to 52 weeks after end of intervention (up to 76 weeks after enrollment)
Number of participants with composite laboratory safety abnormalities
Participants with at least one occurrence of any of the following during the safety follow-up period: elevated aspartate aminotransferase, elevated total bilirubin, or lymphopenia.
Time frame: From first dose to 52 weeks after end of intervention (up to 76 weeks after enrollment)
Number of participants with composite renal safety events
Participants with at least one occurrence of any of the following during the safety follow-up period: new-onset or worsening albuminuria, increased serum creatinine, or decreased estimated glomerular filtration rate.
Time frame: From first dose to 52 weeks after end of intervention (up to 76 weeks after enrollment)
Number of participants with hypoglycemia
Participants with at least one episode of hypoglycemia during the safety follow-up period.
Time frame: From first dose to 52 weeks after end of intervention (up to 76 weeks after enrollment)
Number of participants with severe hypoglycemia
Participants with at least one episode of severe hypoglycemia during the safety follow-up period.
Time frame: From first dose to 52 weeks after end of intervention (up to 76 weeks after enrollment)
Number of participants with ketosis
Participants with at least one episode of ketosis during the safety follow-up period.
Time frame: From first dose to 52 weeks after end of intervention (up to 76 weeks after enrollment)
Number of participants with diabetic ketoacidosis
Participants with at least one episode of diabetic ketoacidosis during the safety follow-up period.
Time frame: From first dose to 52 weeks after end of intervention (up to 76 weeks after enrollment)
Plan to share: No — Deidentified individual participant data will not be shared due to institutional policies, ethical requirements, participant consent limitations, and data protection considerations.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Dec 2028, 32 months after the start.
Of 19 phase 2/3 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 32 months is above that.
How these figures are worked out, and which studies are left out of them.
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