A Phase 2 interventional study of Cyclosporin and ILT101 in Type 1 Diabetes, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 16 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
Type 1 diabetes (T1D) is caused by the destruction of insulin-producing cells by effector T cells (Teffs), due to a deficiency of regulatory T cells (Tregs).
Ciclosporin effectively blocks the Teffs and controls diabetes, but cannot be considered as a long-term treatment. Low-dose interleukin-2 (ld IL-2) activates and expands Tregs in humans.
Hence, Ld IL-2 in patients in whom the autoimmune process was blocked early by a short treatment (2 months) of cyclosporine should restore immune homeostasis and maintain some insulin production over the long term.
Primary Objective :
Tregs' response profile, after 4 administrations of 1MIU/day of IL-2 (Day 63-66) in patients with recently diagnosed type 1 diabetes who have been treated with ciclosporin for 2 months.
Primary assessment criterion:
Change in Tregs values at D67 compared to D63 (post-ciclosporin values)
Secondary objectives and secondary assessment criteria:
Change in residual insulin secretion
Experimental design:
This is a monocentric, randomized, placebo controlled, double-blind trial in parallel-groups, evaluating a treatment by cyclosporine 7mg/kg/day during 2 months followed by ILT-101/placebo, 1 MIU daily for 5 days and 1 MIU every week, during 10 months.
Population involved:
Male or female, aged between 16 and 35 years, with recent diagnosis of type 1 diabetes (\< 3 months).
Number of subjects: 24 Inclusion period: 12 months Duration of patient participation: 24 months (treatment period: 12 months, follow-up period: 12months) Total duration of the study: 37 months
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 24 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Age at inclusion between ≥ 16 years old (Tanner 5 pubertal stage) and ≤ 45 years old
If the patient is a minor, the signatures of both parents and of the child will be collected (or the legal representative if only one parent is alive).
Exclusion Criteria:
Known contraindications to IL2 treatment:
Ciclosporin during 2 months (for all patients) followed by ILT-101 during 10 months
Drug: Cyclosporin · Drug: ILT101
Ciclosporin during 2 months (for all patients) followed by placebo during 10 months
Drug: Cyclosporin · Drug: Placebo
• Ciclosporin: 5mg/kg, twice a day, oral, between Day 1 and Day 60
• ILT-101: 1MIU/day in a volume of 1 ml; subcutaneous injection every day during 5 consecutive days and then every week between Day 63 and Day 354.
• Placebo with an identical formulation and regimen of injections i.e. Subcutaneous injection every day (5 consecutive days) then then every week between Day 63 and Day 354.
Treg variation
Change in Tregs values at Day 67 compared to Day 63 (post-ciclosporin value)
Time frame: From Day 63 to Day 67
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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to month 24
Plan to share: No
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Assistance Publique - Hôpitaux de Paris