1,050
Participants
Start Date
February 7, 2018
Primary Completion Date
June 28, 2024
Study Completion Date
June 28, 2024
Oral Insulin
treatment starting at 4 months - 7 months until age 3.0 years; dose escalation scheme: daily treatment with 7.5 mg or placebo for 2 months; increasing to daily treatment with 22.5 mg or placebo for the following 2 months; increasing to daily treatment with 67.5 mg or placebo until the end of the treatment period.
Placebo
treatment starting at age 4 months - 7 months until age 3.0 years; daily treatment with insulin or placebo capsules containing filling substance (microcrystalline cellulose).
University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven, Leuven, Belgium, Leuven
AUF DER BULT, Kinder- und Jugendkrankenhaus, Hanover, Germany, Hanover
Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Munich, Germany, Munich
Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, CRTD/DFG-Forschungszentrum für Regenerative Therapien, Dresden, Germany, Dresden
Medical University of Warsaw, Department of Paediatrics, Warsaw, Poland, Warsaw
Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS, University Hospital MAS, Malmo, Sweden, Malmo
Department of Paediatrics Clinical Vaccine Research and Immunisation Education, Children's Hospital, Headington, Oxford, UK, Oxford
Helmholtz Zentrum München
INDUSTRY
University Hospital Carl Gustav Carus
OTHER
Kinderkrankenhaus auf der Bult
OTHER
Skane University Hospital
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Medical University of Warsaw
OTHER
University of Oxford, Clinical Vaccine Research and Immunisation Education
UNKNOWN
Technical University of Munich
OTHER