EUCTR2017-003088-36-GBActive, not recruitingPhase 1
GPPAD-POInT (Global Platform of Autoimmune Diabetes – Primary Oral Insulin Trial) Oral Insulin Therapy for Prevention of Autoimmune Diabetes - GPPAD-POInT (Global Platform of Autoimmune Diabetes – Primary Oral Insulin Trial)
Technische Universität München, Represented by the school of medicine0 sites1,040 target enrollmentStarted: October 24, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,040
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
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:
- •A) 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.
- •B) 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.
- •3. Solid foods introduced into diet of infant
- •4. Written informed consent signed by the custodial parent(s).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1040
- •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
Exclusion Criteria
- •1. Concomitant disease or treatment that may interfere with the assessments, as judged by the investigators.
- •2. Any condition that could be associated with poor compliance.
- •3. Any medical condition or medical condition coexisting, which, in the opinion of the investigator, may jeopardize the participant’s safe participation in the study.
- •4. Diagnosis of diabetes at the time of recruitment.
- •5. Participation in another clinical trial.
Investigators
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