Patient with newly diagnosed (≤ 3 months) type 1 diabetes stage 3
Conditions
Brief summary
Variation in Tregs values at D70 compared with post-ciclosporin values (D63)
Detailed description
Compliance with ciclosporin and ILT-101/placebo, Tolerance: tolerance will be assessed from D1 to D719 by means of a clinical examination, measurement of vital signs, a systematic biological check-up and collection of adverse events at every visit., Evolution of residual insulin secretion, Change in Tregs values at M3 (J88), M6 (J179), M9 (J270), M12 (J361) and after treatment discontinuation at M18 (J536) and M24 (J719) compared to baseline and post-ciclosporin values (J63)
Interventions
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation in Tregs values at D70 compared with post-ciclosporin values (D63) | — |
Secondary
| Measure | Time frame |
|---|---|
| Compliance with ciclosporin and ILT-101/placebo, Tolerance: tolerance will be assessed from D1 to D719 by means of a clinical examination, measurement of vital signs, a systematic biological check-up and collection of adverse events at every visit., Evolution of residual insulin secretion, Change in Tregs values at M3 (J88), M6 (J179), M9 (J270), M12 (J361) and after treatment discontinuation at M18 (J536) and M24 (J719) compared to baseline and post-ciclosporin values (J63) | — |
Countries
France
Outcome results
None listed