Dose Finding Study of Il-2 at Ultra-low Dose in Children With Recently Diagnosed Type 1 Diabetes

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 27, 2013

Primary Completion Date

July 8, 2016

Study Completion Date

March 16, 2017

Conditions
Type 1 Diabetes
Interventions
DRUG

Dose D1 of interleukin-2

subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period).

DRUG

placebo

subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period).

DRUG

Dose D2 of Interleukin-2

subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period).

DRUG

Dose D3 of interleukin-2

subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period).

Trial Locations (6)

75015

CIC pédiatrique - CHU de Necker, Paris

Service d'endocrinologie pédiatrique - CHU de Necker, Paris

75019

CIC 9202 CHU Rober Débré, Paris

Service d'endocrinologie Diabétologie pédiatrique CHU Robert Débré, Paris

94275

Service d'Endocrinologie Pédiatrique, Le Kremlin-Bicêtre

30029 cedex 9

Service de Pédiatrie - CHU de Nîmes, Nîmes

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT01862120 - Dose Finding Study of Il-2 at Ultra-low Dose in Children With Recently Diagnosed Type 1 Diabetes | Biotech Hunter | Biotech Hunter