| Trial ID: | L7253 |
| Source ID: | NCT02411253
|
| Associated Drug: |
Rhil-2
|
| Title: |
Low-dose rhIL-2 in Patients With Recently-diagnosed Type 1 Diabetes
|
| Acronym: |
DIABIL-2
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: rhIL-2|DRUG: Placebo
|
| Outcome Measures: |
Primary: AUC (T0-T120) of serum C-peptide, determined after a mixed meal tolerance test at month 12, compared to baseline., Baseline, month12 | Secondary: Serum concentrations of C-peptide, month 3, month 6, month 9, month 15|AUC (T0-T120) of serum C-peptide after a mixed meal tolerance test after treatment discontinuation, month 15|Diabetic monitoring (insulin use), baseline, Day 1, Day 5, month 1, month 3, month 6, month 9, month 12, month 15, month 18, month 21.|HbA1c and IDAA1c score, baseline, month 3, month 6, month 9, month 12, month 15|Number of hypoglycaemic episodes (< 0.5 g/L on capillary sample) over 15 days before each visit., baseline, Day 1, Day 5, month 1, month 3, month 6, month 9, month 12, month 15, month 18, month 21|Number of clinically significant symptomatic episodes of hypoglycaemia between each visit., baseline, Day 1, Day 5, month 1, month 3, month 6, month 9, month 12, month 15, month 18, month 21|Change in Tregs (expressed as percentage of CD4 and absolute numbers) at day 5 compared to baseline., Baseline, Day 5.|Change in trough level of Tregs (%CD4+ and absolute numbers) at month 1, month 3, month 6, month 9, month 12, compared to baseline; and then month 15 and 24 after treatment discontinuation., Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 24|Change in Foxp3 gene methylation, Day 1, Day 5, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15|Cytokines and chemokines assays at day 5, month 1, month 3, month 6, month 9, and month 12 compared to baseline and then month 15 and month 24 after treatment discontinuation., Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 24|Transcriptome analysis., Transcriptome analysis on whole PBMCs will allow analysis of changes in inflammation-related signatures, as already described in Saadoun et al. NEJM, 2011., Baseline, Month 6, Month 12|Genotyping at baseline, Genotyping will be used to assess genetic variation (polymorphisms) associated with T1D, such as those linked to IL2RA, PTPN22, CTLA-4..., baseline|Treg phenotype and functionality in adults and adolescents only including pStat5 analysis, Day 1, Day 5, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15|Clinical examination., Baseline Day 1, Day 5, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24|Height/weight and pubertal stage especially for children and adolescents., Based on Tanner staging (Tanner J. M. 1986)., Baseline, Month 12, Month 24|Routine laboratory tests, Biochemistry, Liver function, Baseline Day 1, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24|Haematology, Baseline Day 1, Day 5, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24|Detection of IL-2 auto-antibodies, Day1, Month 6, Month 12|T cells repertory, Day 1, Day 5, Month 6, Month 12|Intestinal microbiota., Baseline, Month 6, Month 12|Adverse event., Throughout the study., Baseline, Day 1, 2, 3, 4, 5, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
|
| Sponsor/Collaborators: |
Sponsor: Assistance Publique - Hôpitaux de Paris | Collaborators: Iltoo Pharma
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
141
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-06
|
| Completion Date: |
2022-11
|
| Results First Posted: |
|
| Last Update Posted: |
2023-08-14
|
| Locations: |
Pediatric Department, Centre Hospitalier Régional de la Citadelle, Liège, Province De Liège, 4000, Belgium|UZ - Diabetes voor Kinderen en Adolescenten-Leuven, Leuven, 3000, Belgium|CHU UCL Namur - site Godinne, Yvoir, 1-B-5530, Belgium|Centre d'Investigations Cliniques, CHU-HOPITAL HAUTEPIERRE, Strasbourg, Alsace, 67098, France|Centre d'Investigations Cliniques, HÔPITAL CIVIL, Strasbourg, Alsace, 67098, France|Service de pédiatrie 1CHU de HAUTEPIERRE, Strasbourg, Alsace, 67098, France|Structure d'Endocrinologie-Diabète-Nutrition et Addictologie HOPITAUX UNIVERSITAIRES NHC, Strasbourg, Alsace, BP421 - 67091, France|Service d'endocrinologie, diabétologie, maladies métaboliques, et nutrition, CHU de Bordeaux, Hôpital Haut Levêque, Pessac, Aquitaine, 33604, France|Service d' Endocrinologie HOPITAL CAVALE BLANCHE, Brest, Brittany, 29609, France|Service de Pédiatrie, HOPITAL MORVAN, Brest, Brittany, 29609, France|Service de Pédiatrie CHRU DE NANTES, Nantes, Brittany, 44093, France|Service d' Endocrinologie Diabétologie CHRU DE RENNES, Rennes, Brittany, 35033, France|Médecine pédiatrique, CHU Jean Minjoz, Besançon, Franche-Compté, 59037, France|Service Diabétologie -Endocrinologie, CHU Jean Minjoz, Besançon, Franche-Comté, 59037, France|CIC Paris-Est (Adultes), Hôpitaux Universitaires Pitié-Salpêtrière, Charles Foix, Paris, Ile De France, 75013, France|CIC pédiatrique Hôpital Necker Enfants Malades, Paris, Ile De France, 75015, France|Endocrinologie gynécologie diabétologie pédiatriques, Hôpital Universitaire Necker Enfants Malades., Paris, Ile De France, 75015, France|CIC Pédiatrique, Hôpital d'enfants Robert Debré, Paris, Ile De France, 75019, France|Institut E3M, Hôpital Pitié-Salpêtrière, Paris, Ile-de France, 75013, France|Service d'Endocrinologie Pédiatrique, Hôpital d'enfants Robert Debré, Paris, Ile-de France, 75019, France|Service Pédiatrie - Gastro-entérologie, Hépatologie, Nutrition, Diabétologie, Hôpital des Enfants Pôle Enfants, Toulouse, Midi Pyrénnées, 31059 Toulouse cedex 9, France|CHRU de Lille, Hôpital Claude Huriez Service d'endocrinologie, Lille, Nord-Pas-de-Calais, 59037, France|Service d' Endocrinologie, maladies métaboliques HOPITAL NORD, Marseille, Paca, 13015, France|Service de Nutrition - Maladies Métaboliques - Endocrinologie HOPITAL DE LA CONCEPTION, Marseille, Paca, 13385, France|Hopital G&R Laënnec , Endocrinologie, Maladies Métaboliques et Nutrition, Saint Herblain, Pays De La Loire, 44093 NANTES Cedex 1, France|Unité d'Endocrinologie et Diabétologie Pédiatriques, CHU de Marseille, Hôpital La Timone Enfants, Marseille, Provence-Alpes-Côte-d'Azur, 13385 Marseille Cedex 5, France|Endocrinologie-Diabétologie-Maladies de la nutrition, Centre Hospitalier Lyon-Sud, Lyon, Rhones-Alpes, 69495, France|Service d'Endocrinologie pédiatrique - HFME, Bron, 69677, France|Division of Endocrinology and Diabetology, Department of Internal Medicine II, University Hospital of Freiburg, Freiburg, Baden-Württemberg, 79106, Germany|Division of Endocrinology, Diabetology and Metabolic Diseases, University Hospital of Freiburg, Department for children and adolescents, Freiburg, Baden-Württemberg, 79106, Germany|Institute of Diabetes Research, Helmholtz Zentrum München, München, Bayern, D 80804, Germany|Center for Pediatric and Adolescent Diabetes Care and Research, Rotterdam, Randstad Holland, 3011 TG Rotterdam, Netherlands|Dept. of Clinical Sciences Lund University, Skåne University Hospital., Malmö, Öresund Region, 205 02 Malmö, Sweden|Endocrinology and Diabetes department, University Hospital of Basel, Basel, Bâle-Ville, 4031 Basel, Switzerland
|
| URL: |
https://clinicaltrials.gov/show/NCT02411253
|
