Fr1da Insulin Intervention

Plain-language summary

This study looks at oral insulin compared with placebo to see its effect on the development of type 1 diabetes in children. Children aged 2 to 12 who test positive for at least two islet autoantibodies and have normal blood sugar could take part. 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

12/11/2015

Estimated completion

9/30/2024

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. Written informed consent signed by either parent(s) or legal guardian(s).
2. Children aged 2 years to 12 years.
3. Positive for at least two islet autoantibodies out of autoantibodies to glutamic acid decarboxylase (GAD65), to insulin (IAA), autoantibodies to IA-2 (IA2A), or autoantibodies to zink transporter 8 (ZnT8A) (time between screening sample collection and randomization must not exceed 90 days).
4. Normoglycemia assessed by oral glucose tolerance test (OGTT).
5. Participation in an observational study that regularly monitors diabetes development

Exclusion Criteria:

Participants meeting any of the following criteria will NOT be eligible for inclusion into the study:

1. dysglycaemia or overt hyperglycemia (diabetes)
2. Concomitant disease or treatment that may interfere with assessment or cause immunosuppression, as judged by the investigators.
3. Current participation in another intervention trial.
4. Any condition that could be associated with poor compliance.