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Clinical Trial Details

Trial ID: L3106
Source ID: NCT01862120
Associated Drug: Dose D1 Of Interleukin-2
Title: Dose Finding Study of Il-2 at Ultra-low Dose in Children With Recently Diagnosed Type 1 Diabetes
Acronym: DFIL2-Child
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: Dose D1 of interleukin-2|DRUG: placebo|DRUG: Dose D2 of Interleukin-2|DRUG: Dose D3 of interleukin-2
Outcome Measures: Primary: Treg response following the induction cure period, expressed as % total CD4 cells, day 5 | Secondary: Fasting plasma concentration of C-peptide, at Day 0, 99, 183, 267, 351, 436|C-peptide AUC response to a mixed meal tolerance test, at baseline, at months 6, 12, 15|IDAA1C score, is a score defined as A1C (percent) + \[4 x insulin dose (units per kilogram per 24 h)\] without unit, at baseline, at months 3, 6, 9, 12, 15|HbA1c, at baseline, at months 3, 6, 9, 12, 15|Treg response after the last administration, day 351, day 436|Treg response during the maintenance period compare to the baseline, Treg response expressed as the % / CD4 will be measured several times, day 15, day 29, day 43, day 99, day 183, day 267
Sponsor/Collaborators: Sponsor: Assistance Publique - Hôpitaux de Paris
Gender: ALL
Age: CHILD
Phases: PHASE2
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2013-06-27
Completion Date: 2017-03-16
Results First Posted:
Last Update Posted: 2020-11-12
Locations: Service d'Endocrinologie Pédiatrique, Le Kremlin Bicetre, 94275, France|Service de Pédiatrie - CHU de Nîmes, Nimes, 30029 cedex 9, France|CIC pédiatrique - CHU de Necker, Paris, 75015, France|Service d'endocrinologie pédiatrique - CHU de Necker, Paris, 75015, France|CIC 9202 CHU Rober Débré, Paris, 75019, France|Service d'endocrinologie Diabétologie pédiatrique CHU Robert Débré, Paris, 75019, France
URL: https://clinicaltrials.gov/show/NCT01862120