GPPAD-POInT (Global Platform of Autoimmune Diabetes - Primary Oral Insulin Trial)
Diabetes Mellitus, Type 1
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 1 focused on measuring Type 1 diabetes, T1D, diabetes mellitus, oral insulin, oral tolerance, autoantigen, self tolerance, prevention, at risk for developing type 1 diabetes, juvenile diabetes, autoimmune diabetes
Eligibility Criteria
Inclusion Criteria:
1. Infant between the ages of 4 months and 7 months at the time of randomization.
2. A high genetic risk (>10%) to develop beta-cell autoantibodies by age 6 years:
- For infants without a first degree family history of type 1 diabetes, high genetic risk is defined as a DR3/DR4-DQ8 or DR4-DQ8/DR4-DQ8 genotype, and a genetic risk score that is >14.4.
- For infants with a first degree family history of type 1 diabetes, high genetic risk is defined as having HLA DR4 and DQ8, and none of the following protective alleles: DRB1*1501, DQB1*0503.
- Solid foods introduced into diet of infant
- Written informed consent signed by the custodial parent(s).
Exclusion Criteria:
- Concomitant disease or treatment that may interfere with the assessments, as judged by the investigators.
- Any condition that could be associated with poor compliance.
- Any medical condition or medical condition coexisting, which, in the opinion of the investigator, may jeopardize the participant's safe participation in the study.
- Diagnosis of diabetes at the time of recruitment.
- Participation in another clinical trial.
Sites / Locations
- University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven, Leuven, Belgium
- Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Munich, Germany
- AUF DER BULT, Kinder- und Jugendkrankenhaus, Hanover, Germany
- Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, CRTD/DFG-Forschungszentrum für Regenerative Therapien, Dresden, Germany
- Medical University of Warsaw, Department of Paediatrics, Warsaw, Poland
- Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS, University Hospital MAS, Malmo, Sweden
- Department of Paediatrics Clinical Vaccine Research and Immunisation Education, Children's Hospital, Headington, Oxford, UK
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
oral insulin capsule (dose escalation using 3 dose strengths)
Placebo capsule
Dose 1 is 7.5 mg rH-insulin crystals; dose 2 is 22.5 mg rH-insulin crystals; dose 3 is 67.5 mg rH-insulin crystals. The insulin crystals are formulated together with filling substance (microcrystalline cellulose to a total weight of 200 mg) and contained in hard gelatine capsules. The study treatment will be given orally.
Daily treatment with placebo capsules containing filling substance (microcrystalline cellulose).