Intranasal Insulin for Prevention of Type 1 Diabetes
Status:
Unknown status
Trial end date:
2005-08-01
Target enrollment:
Participant gender:
Summary
Children born in Turku, Oulu and Tampere university cities in Finland are screened at birth
for HLA alleles that carry increased risk to or protection from development of type 1
diabetes. Children carrying increased risk are followed at 3-12-month intervals for
development of diabetes-associated autoantibodies. Children having at least two types of
autoantibodies (of the four measured) in at least two consecutively drawn samples are
randomized to receive daily intranasal insulin or placebo in a double-blinded 1:1 trial.
Hypothesis is that intranasal insulin delays or prevents development of clinical type 1
diabetes. The primary outcome measure is development of clinical diabetes.
Phase:
Phase 3
Details
Lead Sponsor:
University of Turku
Collaborators:
Helsinki University Oulu University Hospital Tampere University University of Helsinki University of Tampere