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
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