Primary Intervention With Mucosal Insulin

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Type 1 Diabetes

In brief

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)

Key facts

Study ID

NCT02620553

Run by

University of Colorado, Denver

People needed

25

Starts

2007-09-01

Expected to finish

2014-01-01

Last updated by the study team

2017-04-20

Who can join

Age: 2 and older, up to 7. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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;
• Islet autoantibody negative at time of recruitment.

You may not qualify if…

• Children with any kind of congenital or acquired chronic disease that potentially interfere with the study objectives.
• Prior or current participation in another intervention trial.
• Chronic oral steroid use and/or other chronic oral immunosuppressant

Where it is running

• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.