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: 20.0 Level: PT Classification code 10066284 Term: Diabetes prophylaxis System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-003088-36-GB
• Lead Sponsor: Technische Universität München, Represented by the school of medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-24
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• 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