Prevention of diabetes in very young children (age 4 to 7 month) at high genetic risk for type 1 diabetes with oral insulin therapy

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)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003088-36-GB

Enrollment

1040

Registered

2017-10-24

Start date

2018-04-04

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

risk for type 1 diabetes MedDRA version: 20.0 Level: PT Classification code 10066284 Term: Diabetes prophylaxis System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Product Name: insulin human Pharmaceutical Form: Capsule, hard INN or Proposed INN: INSULIN HUMAN CAS Number: 11061-68-0 Concentration u

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: NA;Primary end point(s): Children will stop treatment the day of the 3rd birthday, or when they develop diabetes.; Timepoint(s) of evaluation of this end point: Visit 1: at baseline Visit 2: month 2 post baseline Visit 3: month 4 post baseline Visit 4: month 8 post baseline Visit 5: at age 18 month Visit 6: at age 24 month Visit 7: at age 30 month Visit 8: at age 3.0 years (End of Treatment) Visit 9: at age 42 month Visit 10: at age 48 month Visit 11: at age 54 month Visit 12: at age 60 month Visit 13: at age 66 month Visit 14: at age 72 month Visit 15: at age 78 month Visit 16: at age 84 month Visit 17: at age 90 month	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: NA;Primary end point(s): Children will stop treatment the day of the 3rd birthday, or when they develop diabetes.; Timepoint(s) of evaluation of this end point: Visit 1: at baseline Visit 2: month 2 post baseline Visit 3: month 4 post baseline Visit 4: month 8 post baseline Visit 5: at age 18 month Visit 6: at age 24 month Visit 7: at age 30 month Visit 8: at age 3.0 years (End of Treatment) Visit 9: at age 42 month Visit 10: at age 48 month Visit 11: at age 54 month Visit 12: at age 60 month Visit 13: at age 66 month Visit 14: at age 72 month Visit 15: at age 78 month Visit 16: at age 84 month Visit 17: at age 90 month

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Belgium, Germany, Poland, Sweden, United Kingdom

Contacts

Public ContactProf. Dr. Anette-G. Ziegler

Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München

anette-g.ziegler@helmholtz-muenchen.de+498931872896

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026