The aim of this study is to look at the safety of taking insulin by mouth. Pre-POINT wants to find a dose that causes an immune response. This response will hopefully delay or prevent the start of type 1 diabetes. Children who join this study will get insulin or a placebo (dummy drug) by mouth every day for 3 -18 months. Participants will be closely followed for the development of diabetes autoantibodies and type 1 diabetes for the whole study.

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Immune System Diseases [C20]; pre-type 1 diabetes (islet autoimmunity in non-diabetic relatives of subjects with type 1 diabetes)

• Registration Number: EUCTR2005-001621-29-DE
• Lead Sponsor: Faculty of Medicine Carl Gustav Carus, University of Technology, Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-07
• Study Completion: 2013-09-15
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Children aged 2 years to 7 years who:
A. have a multiplex first degree family history of T1DM
(both parents, parent and sib, or two sibs);
and a type 1 diabetes susceptible HLA DR4-DQB1*0302 or
DR4-DQB1*0304 haplotype and none of the following HLA
DR or DQB1 alleles:
DR 11
DR 12
DQB1*0602
DR7-DQB1*0303
DR14-DQB1*0503
or
B. have a sibling with T1DM;
and are identical by descent for the HLA DR3/DR4-DQ8 genotype with their
diabetic sibling;
2. Islet autoantibody negative at time of recruitment.

Are the trial subjects under 18? yes
Number of subjects for this age range: 25
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. Children with any kind of congenital or acquired chronic disease that
potentially interfere with the study objectives.
2. Prior or current participation in another intervention trial.
3. Chronic oral steroid use and/or other chronic oral immunosuppressant

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to determine the feasibility, safety and bioavailability of oral insulin administration in children with high genetic risk for type 1 diabetes (T1DM) in a dose escalation primary intervention pilot study.<br><br>To find a dose with proven drug bioavailability to the immune system for use in a phase II/III primary T1DM vaccination trial (POINT study) in genetically at risk subjects.;Secondary Objective: na;Primary end point(s): The development of immunity to insulin (IgG or IgA antibodies, or T cell response to insulin and/or insulin peptides).;Timepoint(s) of evaluation of this end point: at baseline visit, Day 15-, 3 Months-, 6 Months-, 12 months- and 18 months of treatment

Secondary Outcome Measures

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