Clinical Study for Dimethyl Fumarate in Preserving Islet -Cell Function in Type 1 Diabetes Mellitus
Status:
NOT_YET_RECRUITING
Trial end date:
2028-12-31
Target enrollment:
Participant gender:
Summary
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 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.
Phase:
PHASE3
Details
Lead Sponsor:
Nanjing Medical University
Collaborators:
Qilu Pharmaceutical (Hainan) Co., Ltd. The First Affiliated Hospital with Nanjing Medical University