Pre-POINT-Early Study
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
Eligibility Criteria
Inclusion Criteria:
Children aged 6 months to 2 years who have a first degree relative with type 1 diabetes, and have a HLA genotype that includes a HLA DR4-DQB1*0302 or HLA DR4-DQB1*0304 haplotype, and does not include one of the following alleles or haplotypes: DR 11, DR 12, DQB1*0602, DR7-DQB1*0303, DR14-DQB1*0503
and must be
- Islet autoantibody negative at time of recruitment.
Exclusion Criteria:
- Concomitant disease or treatment, which may interfere with assessment or cause immunosuppression, as judged by the investigators.
- Prior or current participation in another intervention trial.
- Any condition that could be associated with poor compliance.
Sites / Locations
- Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Lehrstuhl für Diabetes und Gestationsdiabetes der Technischen Universität München
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).