GPPAD-POInT (Global Platform of Autoimmune Diabetes - Primary Oral Insulin Trial)

• Status: Active, not recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Technische Universität München
• Collaborators: Helmholtz Zentrum München; Kinderkrankenhaus auf der Bult; Medical University of Warsaw; Skane University Hospital; Universitaire Ziekenhuizen Leuven; University Hospital Carl Gustav Carus; University of Oxford, Clinical Vaccine Research and Immunisation Education
• Treatments: Insulin

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:

1. 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.

2. 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).

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.