Intranasal Insulin for Prevention of Type 1 Diabetes

Phase 3

• Conditions: Type 1 Diabetes

• Registration Number: NCT00223613
• Lead Sponsor: University of Turku

Brief 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.

Study Timeline

• Study Start: 1997-08
• Status Verified: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Last Update Submitted: 2006-09-18
• Last Update Posted: 2006-09-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Development of clinical type 1 diabetes

Secondary Outcome Measures

Name	Time	Method
Number and concentration in serum of diabetes-associated autoantibodies (ICA, IAA, GADA and IA-2A)
Responses to intravenous glucose tolerance test
Possible side effects of therapy including hypoglycemia
Changes in serum metabolite patterns (metabolomics)

Trial Locations

Locations (1)

Department of Pediatrics, University of Turku; 🇫🇮 Turku, Finland