Primary prevention of type 1 diabetes in young children at high risk for type 1 diabetes using intranasal insuli
- Conditions
- Risk for type 1 diabetesTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-003379-31-DE
- Lead Sponsor
- Technische Universität München, Fakultät für Medizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 38
1. Written informed consent signed by either both parents or legal guardian(s).
2. Children aged 1 year to 7 years (randomization must be performed prior to 8th birthday) who:
a. have the HLA DR3-DQB1*0201/DR4-DQB1*0302 or HLA DR3-DQB1*0201/DR4-DQB1*0304 genotype
or
b. 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: DR11, DR12, DQB1*0602, or haplotypes: DR7-DQB1*0303, DR14-DQB1*0503, DR13-DQB1*0603
and
3. are islet autoantibody negative (autoantibodies against insulin, GAD, IA-2 and ZnT8) at the time of screening (time between screening sample collection and randomization must not exceed 90 days).
Are the trial subjects under 18? yes
Number of subjects for this age range: 38
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Participants meeting any of the following criteria will NOT be eligible for inclusion into the study:
1. Concomitant disease or treatment that may interfere with assessment or cause immunosuppression, as judged by the investigators.
2. Any condition that could be associated with poor compliance.
3. Any defect or pathology of nasal passage that would preclude application of the intranasal spray.
4. Any moderate to severe intolerance to ingredients of the investigational medicinal product.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether intranasal administration of 440 IU insulin to children with high genetic risk for T1D will induce likely protective IgG or IgA antibody responses to insulin, and/or T-cell responses to insulin and/or proinsulin.;Secondary Objective: not applicable;Primary end point(s): the activation of an immune response (antibody or CD4+ T cell) against insulin;Timepoint(s) of evaluation of this end point: at baseline, month 3 and month 6
- Secondary Outcome Measures
Name Time Method Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable