NCT03364868CompletedPhase 2
GPPAD-POInT (Global Platform of Autoimmune Diabetes - Primary Oral Insulin Trial)
Oral Insulin Therapy for Prevention of Autoimmune Diabetes
Source: ClinicalTrials.gov · Last updated 8 Oct 2024
Brief summary (registry, in English)
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 autoantigens through regular exposure to oral insulin for a period of 29 to 32 months. The hypothesis is that regular exposure to oral insulin throughout the period in life where beta-cell autoimmunity usually initiates will tolerize against insulin and train the body's immune system to recognize the treatment product without reacting adversely to it in a manner seen in children who develop T1D. This immune tolerance induction therapy would reduce the likelihood of beta-cell autoimmunity. The study objective is to determine whether daily administration of oral insulin from age 4 months - 7 months until age 3.00 years to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies and diabetes in childhood.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 1050 (actual)
- First submitted
- 13 Nov 2017
- Start date
- 7 Feb 2018
- Primary completion date
- 28 Jun 2024
- Lead sponsor
- Technical University of Munich
- Diseases
- Type 1 diabetes
- NCT number
- NCT03364868
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 1050
- From 7 Feb 2018 to the primary completion date, 28 Jun 2024
- 7 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant disease or treatment that may interfere with the assessments, as judged by the investigators.
Other illness
- 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.
Other
- Participation in another clinical trial.
Who the study is looking for
- 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).
Age in the registry: 4 months to 7 months · Sex: All · Accepts healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven, Leuven, Belgium Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, CRTD/DFG-Forschungszentrum für Regenerative Therapien, Dresden, Germany Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| AUF DER BULT, Kinder- und Jugendkrankenhaus, Hanover, Germany Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Munich, Germany Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Department of Paediatrics Clinical Vaccine Research and Immunisation Education, Children's Hospital, Headington, Oxford, UK Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Medical University of Warsaw, Department of Paediatrics, Warsaw, Poland Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS, University Hospital MAS, Malmo, Sweden Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.