| Outcome Measures: |
Primary: Differences in AUC in C-peptide stimulation test, Assessment of pancreatic beta cell function by comparing the area under the curve (AUC) in the C-peptide stimulation test: Change in the mean insulin secretion measured on the basis of the C-peptide area under the curve in the stimulation test, 12 months | Secondary: Differences in C-peptide concentration in the stimulation test: change in the insulin secretion measured on the basis of the fasting C-peptide concentration, Fasting C-peptide concentration in the stimulation test, 0, 6, 12 months|Differences in parameters of diabetes control, HbA1c, 0,3,6,9,12 months|Daily insulin requirement, Daily insulin requirement/kg of body mass, 0,3,6,9,12 months|Interleukins, IL1, IL2, IL10, TNF alpha, IFN gamma, 0,6,12 months|Adverse Events occurence, Safety will be evaluated through assessment of AEs, vital signs, physical examinations, USG findings, and laboratory evaluations. Any clinically significant laboratory occurring after study drug initiation must be reported by the investigator as an AE and/or SAE, as appropriate, and must be followed by additional laboratory evaluations until they return to normal range, stabilize, or until the change is no longer clinically relevant. All safety analyses will be conducted using the Safety Analysis Set. Adverse event data will be presented and tabulated according to MedDRA classification., 0,3,6,9,12 months|Differences in C-peptide concentration in the stimulation test: change in the insulin secretion measured on the basis of the fasting C-peptide concentration, Maximum C-peptide concentration, 0,6,12 months|Diabetes control and glucose fluctuations, Mean blood glucose with standard deviation, 0,3,6,9,12 months|Differences in glucose fluctuations, Glucose variability index (CV%), 0,3,6,9,12 months|Parameter of glucose fluctuations, Time in range 70-180mg/dl, 0,3,6,9,12 months|Difference in autoantibodies, Difference in anti-insulin IAA antibodies, antibodies against glutamic acid decarboxylase (GADA), antibodies to tyrosine phosphatase (IA2A), anti-zinc transporter antibodies 8 determination., 0,6,12 month|Genetical analysis, WES Whole Exome Sequencing and HLA, 1 per study
|
