Clinical Research Directory

Inclusion Criteria: 1. Confirmed diagnosis of type 1 diabetes mellitus. 2. Able to complete randomization and initiate treatment with the study drug within 100 days of being formally diagnosed with type 1 diabetes. 3. Peak stimulated C-peptide level ≥ 0.2 pmol/mL during the mixed-meal tolerance test performed in the screening period. 4. Tested positive for at least one type 1 diabetes-associated autoantibody. Exclusion Criteria: 1. Presence of any autoimmune disease other than type 1 diabetes mellitus, except for stable autoimmune thyroid disease. 2. Presence of active infection and/or fever. 3. Known current or prior infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), or serological evidence of such infection at screening. 4. Active pulmonary tuberculosis, malignancy, etc. 5. Severe hepatic impairment (AST or ALT \>3 × upper limit of normal), or severe renal impairment or end-stage renal disease (eGFR \< 30 mL/min/1.73 m²). 6. Prior exposure to immunomodulatory agents, including baricitinib, ivarmacitinib, IL-1 receptor antagonists, tocilizumab (anti-IL-6 monoclonal antibody), infliximab (anti-TNF-α monoclonal antibody), interferons, etc. 7. Severe cardiovascular disease such as angina pectoris, myocardial infarction, or stroke within the previous 6 months. 8. Severe gastrointestinal disease. 9. Surgical procedure performed within the past 6 months. 10. Medical, psychological, or social conditions that, in the opinion of the investigator, may interfere with trial safety or proper completion.