Pre-POINT-Early Study

Plain-language summary

This study evaluated how oral insulin, compared with placebo, affects the immune response in young children at high risk of developing type 1 diabetes. It enrolled children aged 6 months to 2 years who had a first-degree relative with type 1 diabetes and carried certain HLA genotypes. It was conducted in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Technical University of Munich

Intervention

Oral Insulin, Placebo

Start date

8/1/2015

Estimated completion

12/1/2017

Countries

Germany

Related genes

Locations

• München, Germany

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Children aged 6 months to 2 years who have a first degree relative with type 1 diabetes, and have a HLA genotype that includes a HLA DR4-DQB1\*0302 or HLA DR4-DQB1\*0304 haplotype, and does not include one of the following alleles or haplotypes: DR 11, DR 12, DQB1\*0602, DR7-DQB1\*0303, DR14-DQB1\*0503

   and must be
2. Islet autoantibody negative at time of recruitment.

Exclusion Criteria:

1. Concomitant disease or treatment, which may interfere with assessment or cause immunosuppression, as judged by the investigators.
2. Prior or current participation in another intervention trial.
3. Any condition that could be associated with poor compliance.