PINIT Study: Primary Intranasal 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, intranasal insulin, mucosal tolerance, autoantigen, self tolerance, prevention, at risk for developing type 1 diabetes, juvenile diabetes
Eligibility Criteria
Inclusion Criteria:
Children aged 1 year to 7 years (randomization must be performed prior to 8th birthday) who
- have the HLA DR3-DQB1*0201/DR4-DQB1*0302 or the HLA DR3-DQB1*0201/DR4-DQB1*0304 genotype or
- have a first degree relative with type 1 diabetes, and have a HLA genotype that includes the HLA DR4-DQB1*0302 or HLA DR4-DQB1*0304 haplotype, and does not include one of the following alleles DR 11, DR 12, DQB1*0602, or haplotypes DR7-DQB1*0303, DR14-DQB1*0503, DR13-DQB1*0603 and must be
- Islet autoantibody negative (autoantibodies against insulin, GAD, IA-2 and ZnT8) at time of screening.
Exclusion Criteria:
- Concomitant disease or treatment, which may interfere with assessment or cause immunosuppression, as judged by the investigators.
- Any condition that could be associated with poor compliance.
- Any defect or pathology of nasal passage, which would preclude application of the intranasal spray.
- Any moderate to severe intolerance to ingredients of the investigational medicinal product.
Sites / Locations
- Klinik und Poliklinik für Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, 01307 Dresden, Germany
- 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
intranasal insulin
intranasal placebo
rH-insulin formulation and for a dose of 440 IU insulin to the nasal mucosa. Treatment will be administered daily for the first 7 intervention days, and one day per week thereafter for 6 months.
Treatment with placebo nasal spray daily for the first 7 intervention days and one day per week thereafter for 6 months.