Outcome Measures: |
Primary: Treg variation, Change in Tregs values at Day 67 compared to Day 63 (post-ciclosporin value), From Day 63 to Day 67 | Secondary: Change in Area under curve (AUC (T0-T120) of serum C-peptide at month 6, Change in Area under curve (AUC (T0-T120) of serum C-peptide after mixed-meal tolerance test compared to baseline 2. Variation in HbA1c value (in %) 3. Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + \[4 × insulin dose (in international units per kilogram per 24 h)\]. 4. Change in Insulin requirement (insulin dose in international units per kilogram per 24 h 5. Change in Tregs values (in %/CD4+) at month 3, month 6, month 9, month 12 and after treatment interruption at month 18 and month 24 compared to baseline and post-cyclosporin values (Day 63), up to month 6|Change in Area under curve (AUC (T0-T120) of serum C-peptide at month 12, Change in Area under curve (AUC (T0-T120) of serum C-peptide after mixed-meal tolerance test compared to baseline 2. Variation in HbA1c value (in %) 3. Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + \[4 × insulin dose (in international units per kilogram per 24 h)\]. 4. Change in Insulin requirement (insulin dose in international units per kilogram per 24 h 5. Change in Tregs values (in %/CD4+) at month 3, month 6, month 9, month 12 and after treatment interruption at month 18 and month 24 compared to baseline and post-cyclosporin values (Day 63), up to month 12|Change in Area under curve (AUC (T0-T120) of serum C-peptide at month 24, Change in Area under curve (AUC (T0-T120) of serum C-peptide after mixed-meal tolerance test compared to baseline 2. Variation in HbA1c value (in %) 3. Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + \[4 × insulin dose (in international units per kilogram per 24 h)\]. 4. Change in Insulin requirement (insulin dose in international units per kilogram per 24 h 5. Change in Tregs values (in %/CD4+) at month 3, month 6, month 9, month 12 and after treatment interruption at month 18 and month 24 compared to baseline and post-cyclosporin values (Day 63), up to month 24|Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at day 63,, Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to baseline, up to day 63|Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 3, Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to baseline, up to month 3|Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 6, Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to baseline, up to month 6|Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 9, Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to baseline, up to month 9|Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 12, Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to baseline, up to month 12|Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 18, Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to baseline, up to month 18|Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 24, Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to baseline, up to month 24|Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at day 63, Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + \[4 × insulin dose (in international units per kilogram per 24 h)\] during the treatment period and during the 1 year follow-up period compared to baseline, up to day 63|Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period up to month 3, Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + \[4 × insulin dose (in international units per kilogram per 24 h)\] during the treatment period and during the 1 year follow-up period compared to baseline, up to month 3|Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at month 6, Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + \[4 × insulin dose (in international units per kilogram per 24 h)\] during the treatment period and during the 1 year follow-up period compared to baseline, up to month 6|Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at month 9, Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + \[4 × insulin dose (in international units per kilogram per 24 h)\] during the treatment period and during the 1 year follow-up period compared to baseline, up to month 9|Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at month 12, Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + \[4 × insulin dose (in international units per kilogram per 24 h)\] during the treatment period and during the 1 year follow-up period compared to baseline, up to month 12|Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at day month 18, Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + \[4 × insulin dose (in international units per kilogram per 24 h)\] during the treatment period and during the 1 year follow-up period compared to baseline, up to month 18|Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at month 24, Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + \[4 × insulin dose (in international units per kilogram per 24 h)\] during the treatment period and during the 1 year follow-up period compared to baseline, up to month 24|Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at day 30, Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline, up to day 30|Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at day 63, Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline, up to day 63|Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 3, Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline, up to month 3|Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 6, Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline, up to month 6|Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 9, Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline, up to month 9|Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 12, Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline, up to month 12|Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 18, Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline, up to month 18|Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 24, Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline, up to month 24|Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at day 30, Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values, up to day 30|Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at day 63, Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values, up to day 63|Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 3, Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values, up to month 3|Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 6, Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values, up to month 6|Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 9, Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values, up to month 9|Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 12, Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values, up to month 12|Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 18, Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values, up to month 18|Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 24, Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values, up to month 24|incidence of adverse events at day 30, incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24, up to day 30|incidence of adverse events at day 63, incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24, up to day 63|incidence of adverse events at month 3, incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24, up to month 3|incidence of adverse events at month 6, incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24, up to month 6|incidence of adverse events at month 9, incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24, up to month 9|incidence of adverse events at month 12, incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24, up to month 12|incidence of adverse events at month 18, incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24, up to month 18|incidence of adverse events at month 24, incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24, up to month 24
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