Intranasal Insulin for Prevention of Type 1 Diabetes

• Status: Unknown status
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Turku
• Collaborators: Helsinki University; Oulu University Hospital; Tampere University; University of Helsinki; University of Tampere
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• children carrying HLA-conferred genetic risk for developing type 1 diabetes

• have had at least two types of autoantibodies of ICA, IAA, GADA and IA-2A in at least two consecutive blood samples drawn at least 3 months apart

• age at least one year

Exclusion Criteria:

• severe other disease

• age above 15 years