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Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary endpoint revised
    • Start date changed from estimate of Dec 31, 2025 to Jan 27, 2026
    • Secondary endpoints: 11 to 10
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Purpose of the Clinical Trial: This clinical trial aims to investigate whether dimethyl fumarate can treat adults with newly diagnosed type 1 diabetes and to evaluate the safety profile of dimethyl fumarate. Primary Research Questions: Does dimethyl fumarate protect pancreatic beta-cell function in adults with newly diagnosed type 1 diabetes? What medical issues may arise in individuals taking dimethyl fumarate? Study Design: Researchers will compare dimethyl fumarate with a placebo (an identical substance without active ingredients) to determine whether Dimethyl fumarate can effectively treat type 1 diabetes. Participant Activities: Take dimethyl fumarate or placebo orally twice daily for 24 weeks. Attend on-site visits every 4 weeks during the intervention period and every 12 weeks after the intervention for examinations and assessments. Record symptoms, blood glucose control, islet function, and insulin usage throughout the trial.
Trial Details
NCT Number NCT07258394
Lead Sponsor Nanjing Medical University
Collaborators: The First Affiliated Hospital with Nanjing Medical University, Qilu Pharmaceutical (Hainan) Co., Ltd.
Conditions
(from sponsor)		 Type 1 Diabetes
Related terms Diabetes Mellitus, Type 1
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov