The purpose of this study is to investigate the therapeutic effect and safety of Sorafenib in T1DM patients.
Subjects with written informed consent;
Age: 18-60 years;
Diagnosis of T1DM according to ADA criteria within 1 year prior to starting study drug;
Islet autoantibody positivity (one or more of GADA, IA-2A, ZnT8A);
Non-Type 1 Diabetes Mellitus.
Positivity for human immunodeficiency virus
Positive purified protein derivative or interferon-γ release assay suggestive of tuberculosis
Positivity for hepatitis B surface antigen And acute infections (e.g., respiratory, urinary tract, or gastrointestinal infections) must be resolved before reevaluation;
Parallel
Sorafenib
DrugSubjects receive sorafenib 400mg once daily. Insulin therapy will be continued as a routine therapy.
Placebo
DrugSubjects receive placebo 400mg once daily. Insulin therapy will be continued as a routine therapy.
The primary endpoint of the study is the change from baseline of serum C-peptide area under the curve (AUC) over 2 hours following a mixed meal
The change from baseline of serum C-peptide (pmol/L)
Change from baseline of serum C-peptide area under the curve (AUC) over 2 hours following a mixed meal
Change from baseline of serum C-peptide area under the curve (AUC) over 2 hours following a mixed meal tolerance test
Change from baseline in glycosylated haemoglobin (HbA1c) levels
Change from baseline in HbA1c (%) levels
Change from baseline in insulin dosage
Change from baseline in insulin dosage, including total dose and units per kilogram
The frequency and severity of hypoglycemic events
Number and rate of hypoglycemic events including Grade 1, 2 and 3
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