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

Phase 1

Conditions: risk for type 1 diabetes
MedDRA version: 21.1Level: PTClassification code 10066284Term: Diabetes prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2017-003088-36-DE

Lead Sponsor: Technische Universität München, Represented by the school of medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1040

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>Visit 2: month 2 post baseline<br>Visit 3: month 4 post baseline<br>Visit 4: month 8 post baseline <br>Visit 5: at age 18 month<br>Visit 6: at age 24 month<br>Visit 7: at age 30 month<br>Visit 8: at age 3.0 years (End of Treatment)<br><br>Visit 9: at age 42 month<br>Visit 10: at age 48 month<br>Visit 11: at age 54 month<br>Visit 12: at age 60 month<br>Visit 13: at age 66 month<br>Visit 14: at age 72 month<br>Visit 15: at age 78 month<br><br>

Secondary Outcome Measures