Type 1 Diabetes MellitusPhase 2/3NCT07548996
Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes
A Phase 2/3 study testing Dimethyl Fumarate Enteric-coated Capsules and Insulin in people with Type 1 Diabetes Mellitus, run by Nanjing Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Dimethyl Fumarate Enteric-coated Capsules and Insulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2026to 31 Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangsu Provincial Hospital
Nanjing, Jiangsu, 210029
Yong Gu, 13814084876, yong.gu@njmu.edu.cn
About this study
Official title: Non-Randomized, Parallel-Controlled, Single-Center, Open-Label Clinical Trial Evaluating the Efficacy and Safety of Dimethyl Fumarate in Preserving Pancreatic β-Cell Function in Adults With Type 1 Diabetes
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.
Read more
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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Dimethyl Fumarate Enteric-coated Capsules, Insulin
- Keywords
- Dimethyl Fumarate, Type 1 Diabetes, Beta-Cell Function
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimethyl Fumarate Enteric-coated CapsulesDrug
Also called DMF
Dimethyl fumarate enteric-coated capsules, initiated at 120 mg twice daily and increased after 7 days to 240 mg twice daily.
InsulinDrug
Standard insulin therapy for type 1 diabetes according to routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Dimethyl Fumarate Plus Standard Insulin Therapy | Experimental | 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. Receives: Drug: Dimethyl Fumarate Enteric-coated Capsules; Drug: Insulin |
| Standard Insulin Therapy | Active comparator | 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. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 weeks after end of intervention (48 weeks after enrollment)
Secondary outcomes (24)
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).
Measured: 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).
Measured: 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).
Measured: 52 weeks after end of intervention (76 weeks after enrollment)
Glycated Hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c) level and change from baseline.
Measured: 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%.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first dose to 52 weeks after end of intervention (up to 76 weeks after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start27 Apr 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Gu, Nanjing Medical University
- Investigators
- Yong Gu, Principal investigator, Department of Endocrinology, Jiangsu Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548996
- Sponsor's protocol ID
- 2026-SR-107
- Status last verified
- Jul 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified individual participant data will not be shared due to institutional policies, ethical requirements, participant consent limitations, and data protection considerations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Randomized, Parallel-Controlled, Single-Center, Open-Label Clinical Trial Evaluating the Efficacy and Safety of Dimethyl Fumarate in Preserving Pancreatic β-Cell Function in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07548996
- Acronym / sponsor ID
- 2026-SR-107
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Dimethyl Fumarate, Type 1 Diabetes, Beta-Cell Function
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dimethyl Fumarate Plus Standard Insulin Therapy | Experimental | Drug: Dimethyl Fumarate Enteric-coated Capsules, Drug: InsulinParticipants 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. |
| Standard Insulin Therapy | Active comparator | Drug: InsulinParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimethyl Fumarate Enteric-coated CapsulesAlso: DMFDimethyl fumarate enteric-coated capsules, initiated at 120 mg twice daily and increased after 7 days to 240 mg twice daily. | Drug | Dimethyl Fumarate Plus Standard Insulin Therapy |
| InsulinStandard insulin therapy for type 1 diabetes according to routine clinical practice. | Drug | Dimethyl Fumarate Plus Standard Insulin Therapy, Standard Insulin Therapy |
Primary outcome
Baseline-Adjusted Geometric Mean Area Under the Serum C-Peptide Curve During a 2-Hour Mixed-Meal Tolerance Test
Time frame: 24 weeks after end of intervention (48 weeks after enrollment)
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).
24 secondary outcomes
Baseline-Adjusted Geometric Mean Area Under the Serum C-Peptide Curve During a 2-Hour Mixed-Meal Tolerance Test
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
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
Time frame: 52 weeks after end of intervention (76 weeks after enrollment)
Glycated Hemoglobin (HbA1c)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: From first dose to 52 weeks after end of intervention (up to 76 weeks after enrollment)
Number of participants with hypoglycemia
Time frame: From first dose to 52 weeks after end of intervention (up to 76 weeks after enrollment)
Number of participants with severe hypoglycemia
Time frame: From first dose to 52 weeks after end of intervention (up to 76 weeks after enrollment)
Number of participants with ketosis
Time frame: From first dose to 52 weeks after end of intervention (up to 76 weeks after enrollment)
Number of participants with diabetic ketoacidosis
Time frame: From first dose to 52 weeks after end of intervention (up to 76 weeks after enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No. Deidentified individual participant data will not be shared due to institutional policies, ethical requirements, participant consent limitations, and data protection considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong Gu principal investigator
Department of Endocrinology, Jiangsu Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dimethyl Fumarate Enteric-coated Capsules and Insulin in people with Type 1 Diabetes Mellitus, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Gu (+86 13814084876, yong.gu@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline-Adjusted Geometric Mean Area Under the Serum C-Peptide Curve During a 2-Hour Mixed-Meal Tolerance Test (time frame: 24 weeks after end of intervention (48 weeks after enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.