Primary Intervention With Mucosal Insulin

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A dose with proven drug bioavailability to the immune system for use in a phase II/III primary T1DM (type 1 diabetes) vaccination trial (POINT study) in genetically at risk subjects.

Study Design Randomized, placebo-controlled, double-blind/double-masked, multi-center, dose escalation primary intervention pilot study.

Accrual Objective 25 (3:2 randomization to active and control arms)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborators: Diabetes Research Institute, Munich, Germany.; German Federal Ministry of Education and Research; Juvenile Diabetes Research Foundation; University Hospital Dresden; University of Bristol
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. Children aged 2 years to 7 years who:

• Have a multiplex first degree family history of T1DM (both parents, parent and sib, or two sibs);

• 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

• Have a sibling with T1DM;

• Identical by descent for the HLA DR3/DR4-DQ8 genotype with their diabetic sibling;

2. Islet autoantibody negative at time of recruitment.

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