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Primary Intervention With Mucosal Insulin — Pre-POINT  

Type 1 Diabetes Clinical Trial

Official title:
Primary Intervention With Mucosal Insulin for Prevention of Type 1 Diabetes in Infants at High Genetic Risk to Develop Diabetes POINT (Primary Oral Insulin Trial) A Dose Finding and Safety Study ( Pre-POINT )

Clinical Trial 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)

Clinical Trial Description

The objective of this study is to determine the feasibility, safety and bioavailability of oral insulin in children with high genetic risk for T1DM in a dose escalation primary intervention pilot study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02620553
Study type Interventional
Source University of Colorado, Denver
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 2007
Completion date January 2014
View Details
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