Status:
COMPLETED
GPPAD-POInT (Global Platform of Autoimmune Diabetes - Primary Oral Insulin Trial)
Lead Sponsor:
Technical University of Munich
Collaborating Sponsors:
Helmholtz Zentrum München
University Hospital Carl Gustav Carus
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
4-7 years
Phase:
PHASE2
Brief Summary
The GPPAD-POInT Study is designed as a randomized, placebo-controlled, double blind, multicentre, multinational primary prevention phase IIb study aiming to induce immune tolerance to beta-cell autoan...
Detailed Description
The GPPAD-POInT-Study aims to determine whether daily administration of oral insulin to children from age 4 months - 7 months with elevated genetic risk for type 1 diabetes reduces the cumulative inci...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2024
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT03364868
Start Date
February 7 2018
End Date
June 28 2024
Last Update
October 8 2024
Active Locations (7)
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1
University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven, Leuven, Belgium
Leuven, Belgium, 3000
2
Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Munich, Germany
Munich, Bavaria, Germany, 80804
3
AUF DER BULT, Kinder- und Jugendkrankenhaus, Hanover, Germany
Hanover, Lower Saxony, Germany, 30173
4
Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, CRTD/DFG-Forschungszentrum für Regenerative Therapien, Dresden, Germany
Dresden, Saxony, Germany, 01307