Type 1 diabetes
Conditions
Interventions
Low-dose group / Medium-dose group / High-dose group:Insulin and hypoglycemic drugs
Dose expansion group:Insulin and hypoglycemic drugs
Sponsors
Zibo Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 65 years old (inclusive of the boundary value), gender not restricted; 2. Diagnosed with autoimmune type 1 diabetes (in accordance with the diagnostic criteria of "Chinese Guidelines for the Diagnosis and Treatment of Type 1 Diabetes (2021 Edition)"), and after 2-hour mixed meal (MMTT) stimulation during the screening period, the C-peptide peak value was >= 0.2 nmol/L; 3. At least one insulin autoantibody was positive, such as glutamic acid decarboxylase autoantibody (GADA), protein tyrosine phosphatase autoantibody (IA-2A), insulin autoantibody (IAA) (without using insulin or insulin treatment within 2 weeks), zinc transporter protein antibody (ZnT8A); 4. Glycated hemoglobin (HbA1c) >= 6.5% and = 18 kg/m^2 and = 1.0 × 10^9/L; (1).Absolute lymphocyte count (LYC) >= 1.0 × 10^9/L; (2).Platelet count (PLT) >= 75 × 10^9/L; (3).Hemoglobin content (HGB) >= 80 g/L; (4). Heart: Left ventricular ejection fraction (LVEF) >= 50%; (5).Cardiac function 1-2 grade; (6). Lung function: Indoor blood oxygen saturation >= 92%; (7).Liver function: Serum total bilirubin (TBIL) <= 1.5 × ULN; (8).Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 × ULN; (9). Kidney function: Serum creatinine (Cr) <= 1.5 × ULN; (10).Glomerular filtration rate (eGFR) .= 60 mL/min/1.73m^2 (calculated by MDRD formula); 7. For pregnant women of childbearing age, the serum or urine pregnancy test results before enrollment must be negative, and they must agree to take acceptable measures to minimize the possibility of pregnancy during the trial; 11.For pregnant women of childbearing age or male patients whose sexual partner is a pregnant woman of childbearing age, effective contraceptive measures must be taken throughout the treatment period and 6 months after the last medication; 8. Agree to abide by the principles and recommendations of "Chinese Guidelines for the Diagnosis and Treatment of Type 1 Diabetes (2021 Edition)" for medical nutrition therapy; 9. Voluntarily participate in the clinical study, understand, be informed of this study, and sign the informed consent form, and be willing to follow all trial procedures.
Exclusion criteria
Exclusion criteria: 1. Active malignant tumors that require treatment, excluding non-melanoma skin cancer or carcinoma in situ (such as breast and cervical cancer); 2. Subjects who have previously undergone organ transplantation or are preparing for organ transplantation; 3. Subjects who received immunosuppressive therapy within 4 weeks prior to enrollment and/or require long-term immunosuppressive treatment during the study, allowing intermittent use of topical, inhaled or nasal corticosteroids; 4. Subjects who experienced any life-threatening bleeding event within 3 months prior to enrollment, including those requiring blood transfusion treatment, surgery or local treatment, and continuous medication; 5. Subjects who had any thromboembolic events in the arteries and veins within 6 months prior to enrollment, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolic disease. Implanted venous infusion ports or catheter-related thrombosis, or superficial venous thrombosis, with stable thrombus after conventional anticoagulation treatment, are excluded. Permissive use of low-dose low-molecular-weight heparin (such as enoxaparin 40 mg/day) for prophylaxis; 6. Severe bleeding tendency or coagulation dysfunction, or undergoing thrombolytic therapy; 7. Uncontrolled hypertension, with systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg after optimal medical treatment, or history of hypertensive crisis or hypertensive encephalopathy; 8. Symptomatic congestive heart failure (New York Heart Association grade II-IV); 1.symptomatic or poorly controlled arrhythmia. History of congenital long QT syndrome or corrected QTc >500 ms (calculated using the Fridericia method); 9. History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired pulmonary function, etc. 10. Active pulmonary tuberculosis (TB), subjects who are currently undergoing anti-TB treatment or have received anti-TB treatment within 1 year before the first administration; 2.active hepatitis B or C virus infections, human immunodeficiency virus (HIV) infections, known syphilis infections; 11. Subjects who had active or poorly controlled severe infections within 4 weeks prior to enrollment, including but not limited to those hospitalized due to infection, bacteremia or severe pneumonia complications (excluding mild urinary and respiratory tract infections); 12. Diabetic complications, such as: (1) ketoacidosis; (2) renal insufficiency (urine protein >=2+, eGFR <60 mL/min/1.73m^2); (3) active or untreated proliferative retinopathy; (4) diabetic foot ulcers; (5) amputation due to diabetes; (6). severe peripheral neuropathy; 13. Subjects who had active or poorly controlled severe infections within 4 weeks prior to enrollment, including but not limited to those hospitalized due to infection, bacteremia or severe pneumonia complications (excluding mild urinary and respiratory tract infections); 14. Subjects who had 2 or more severe, unexplained hypoglycemic events within 6 months prior to enrollment; 15. Unable to complete the mixed meal tolerance test (MMTT), or history of any significant allergy (such as anaphylactic shock) to any component of the mixed meal in the MMTT test; 16. Subjects who had received treatment in other clinical studies within 4 weeks prior to enrollment; 17. Subjects who had received
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CGM;MMTT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic evaluation;Evaluation of peripheral blood immune cell subsets; | — |
Countries
China
Contacts
Public ContactPang Xiaoming
Zibo Central Hospital
Outcome results
None listed