Primary prevention of type 1 diabetes in very young children at high risk for type 1 diabetes using oral insuli

Phase 1

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

• Registration Number: EUCTR2014-005287-15-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: 2015-04-13
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 44

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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 44
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, 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.

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 up to 67.5 mg insulin to young children aged 6 months to 2 years with high genetic risk for T1D induces immune responses to insulin with features of immune regulation.;<br> Secondary Objective: To determine whether daily administration of up to 67.5 mg insulin induces metabolic changes in blood (glucose, insulin and C-peptide levels) of safety concern in infants aged 6 months to 2 years.<br> To determine whether daily administration of up to 67.5 mg insulin to young children aged 6 months to 2 years with high genetic risk for T1D induces immune responses to proinsulin.<br> ;Primary end point(s): GAD, IA-2, or ZnT8 autoantibody positivity in two consecutive samples or diabetes;Timepoint(s) of evaluation of this end point: at abseline, 3 months-, 6 months-, 9 months- and 12 months of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): na;Timepoint(s) of evaluation of this end point: na