Type 1 Diabetes Mellitus
Conditions
Interventions
Placebo Arm:Matching placebo capsules
FMS02 Arm:FMS02 enteric-coated capsules
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who provide written informed consent. 2. Aged 18–65 years. 3. Diagnosed with Type 1 Diabetes Mellitus (per ADA 2024 criteria). 4. Positive for >=2 autoantibodies: Insulin autoantibody (IAA) Glutamic acid decarboxylase autoantibody (GADA) Protein tyrosine phosphatase antibody (IA-2A) Islet cell antibody (ICA) Zinc transporter 8 autoantibody (ZnT8A) Note: For IAA-positive subjects with insulin use >14 days, >=2 additional autoantibodies must be positive. 5. Disease duration =200 pmol/L.
Exclusion criteria
Exclusion criteria: 1. Pregnancy, lactation, or women of childbearing potential not using contraception. 2. Well-controlled glycemia with oral hypoglycemic agents alone. 3. Participation in other diabetes/immune-modulating trials. 4. ALT/AST >3× upper limit of normal (ULN). 5. History of malignancy, uncontrolled autoimmune disorders, or active infections. 6. Alcohol/drug abuse, psychiatric disorders, or conditions unsuitable for trial participation. 7. Use of immunosuppressants within 12 weeks prior. 8. Participation in other drug trials within 12 weeks prior. 9. History of drug allergies, hypersensitivity, or drug addiction. 10. Any condition deemed by investigators to compromise study integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric Mean Area Under the Serum C-Peptide Curve (AUC C-peptide) during a 2-hour Mixed Meal Tolerance Test (MMTT) at Week 24, Adjusted for Baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycemic Control Status;Incidence Rates of Hypoglycemia/Severe Hypoglycemia and Ketosis/Diabetic Ketoacidosis (DKA);Incidence Rates of Flushing, Abdominal Pain, Diarrhea, Nausea, Vomiting, Pruritus, Rash, Proteinuria, Erythema, and Dyspepsia;Serum Profiles of Pro-Inflammatory and Regulatory Cytokines, Along with Other Immunological Mediators;Number, Specificities, and Titers of Islet Autoantibodies;White Blood Cell (WBC) Subpopulation Differentiation;Incidence Rates of Elevated Aspartate Aminotransferase (AST), Elevated Total Bilirubin (TBIL), and Lymphocytopenia;Mean Daily Dose of Exogenous Insulin Used During the 7 Days Preceding Each Study Visit;Incidence Rates of Anaphylaxis, Angioedema, and Opportunistic Infections; | — |
Countries
China
Contacts
Public ContactGu Yong
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed