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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2023
• Main ID: NCT03364868
• Date of registration: 13/11/2017
• Prospective Registration: Yes
• Primary sponsor: Technical University of Munich
• Public title: GPPAD-POInT (Global Platform of Autoimmune Diabetes - Primary Oral Insulin Trial)
• Scientific title: Oral Insulin Therapy for Prevention of Autoimmune Diabetes
• Date of first enrolment: February 7, 2018
• Target sample size: 1050
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03364868
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, Germany, Poland, Sweden, United Kingdom

Key inclusion & exclusion 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.



Age minimum: 4 Months
Age maximum: 7 Months
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 1

Intervention(s)

Drug: Oral Insulin

Other: Placebo

Primary Outcome(s)

The development of persistent confirmed multiple beta-cell autoantibodies [Time Frame: elapsed time from treatment assignment (baseline) to first positive sample visit (>2 beta-cell antibodies) in children who develop persistent confirmed multiple beta-cell antibodies. Primary outcome can develop any time up to last study visit at 7.5 yrs]

The development of diabetes [Time Frame: elapsed time from random treatment assignment (baseline) to the development diabetes (date of diagnosis). This primary outcome measure can develop any time during treatment or follow-up period up to the last study visit at 7.5 years of age]

Secondary Outcome(s)

Persistent confirmed GADA. [Time Frame: elapsed time from treatment assignment (baseline) to the first sample that is positive for GADA in children who develop persistent confirmed GADA. Outcome can develop any time up to the last study visit at 7.5 years of age]

Abnormal glucose tolerance (AGT) defined by dysglycemia or diabetes. [Time Frame: elapsed time from treatment assignment to the date at which abnormal glucose tolerance or diabetes is diagnosed. Outcome can develop any time up to the last study visit at 7.5 years of age]

Any persistent confirmed beta-cell autoantibody or diabetes [Time Frame: elapsed time from treatm. assignm. (baseline) to 1st pos. sample for >1 beta-cell antibody in children who developed persist. confirm. beta-cell antibodies OR diabetes onset, whichever is first. outcome can develop any time up to last visit at 7.5 yr]

Persistent confirmed IAA. [Time Frame: elapsed time from treatment assignment (baseline) to first sample that is positive for IAA in children who develop persistent confirmed IAA. Outcome can develop any time during treatment or follow-up period up to the last study visit at 7.5 years of age.]

Secondary ID(s)

GPPAD-03-POInT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Universitaire Ziekenhuizen KU Leuven

Helmholtz Zentrum München

Skane University Hospital

Kinderkrankenhaus auf der Bult

University Hospital Carl Gustav Carus

Medical University of Warsaw

University of Oxford, Clinical Vaccine Research and Immunisation Education