Dimethyl Fumarate Phase 2 Trial for Type 1 Diabetes Beta-Cell Preservation
ClinicalTrials.gov Studies
Summary
This Phase 2 clinical trial (NCT07548996) will evaluate whether dimethyl fumarate preserves pancreatic beta-cell function in adults with type 1 diabetes. The non-randomized, parallel-controlled, single-center, open-label study plans to enroll 96 participants aged 18 to 65 years meeting ADA 2024 diagnostic criteria, with 32 participants receiving dimethyl fumarate enteric-coated capsules (120 mg twice daily, increasing to 240 mg twice daily after 7 days) plus standard insulin therapy, and 64 participants receiving insulin therapy alone. The 24-week intervention period will be followed by 52 weeks of follow-up, with the primary efficacy endpoint being the baseline-adjusted geometric mean area under the serum C-peptide curve during a 2-hour mixed-meal tolerance test at Week 24.
“Dimethyl fumarate will be initiated at 120 mg twice daily and increased after 7 days to a maintenance dose of 240 mg twice daily.”
About this source
ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.
What changed
This ClinicalTrials.gov registry entry documents a Phase 2 clinical trial investigating dimethyl fumarate for preservation of pancreatic beta-cell function in adults with type 1 diabetes. The study plans to enroll 96 participants in a non-randomized, parallel-controlled design comparing dimethyl fumarate plus insulin therapy against insulin therapy alone over a 24-week intervention with 52 weeks of follow-up. For pharmaceutical companies and clinical investigators, this trial registration indicates an active investigation into disease-modifying approaches for type 1 diabetes beyond standard insulin therapy, with the primary efficacy endpoint focused on C-peptide preservation as a marker of residual beta-cell function.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes
Phase 2 NCT07548996 Kind: PHASE2 Apr 23, 2026
Abstract
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 re...
Conditions: Type 1 Diabetes Mellitus
Interventions: Dimethyl Fumarate Enteric-coated Capsules, Insulin
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.