NCT00223613

Intranasal Insulin for Prevention of Type 1 Diabetes

Intranasal Insulin for Prevention of Type 1 Diabetes in Children Carrying Increased HLA-Conferred Genetic Risk

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (planned)
• Sponsor: University of Turku · Academic / Other
• Sex: All
• Age: 1 Year – 15 Years
• Healthy volunteers: Accepted

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.

Detailed description

Children born in Turku, Oulu and Tampere university cities in Finland are screened at birth for the HLA-DQB1 and DQA1 alleles that carry increased risk to or protection from development of type 1 diabetes. Children carrying increased risk are followed at 3-month intervals until 2 years of age and then at 6-12-month intervals until,15 years of age for development of diabetes-associated autoantibodies (autoantibodies against islet cells, insulin, glutamic acid decarboxylase and IA-2 protein). 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, but serum concentrations of autoantibodies, responses to intravenous glucose tolerance test and possible side effects of therapy are also closely monitored.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	daily intranasal administration of insulin

Timeline

• Start date: 1997-08-01
• Completion: 2005-08-01
• First posted: 2005-09-22
• Last updated: 2006-09-19

Locations

1 site across 1 country: Finland