Fr1da Insulin Intervention - secondary prevention of type 1 diabetes in young children using oral insuli

Phase 1

• Conditions: Risk for type 1 diabetes; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-003028-30-DE
• Lead Sponsor: Technische Universität München, Fakultät für Medizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-11
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 220

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 220
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.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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified