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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00223613
Other study ID # DIPP19942014
Secondary ID JDRF File # 4-19
Status Recruiting
Phase Phase 3
First received September 13, 2005
Last updated September 18, 2006
Start date August 1997
Est. completion date August 2005

Study information

Verified date August 2005
Source University of Turku
Contact Olli G Simell, MD, PhD
Phone +358-2-313-2466
Email olli.simell@utu.fi
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year to 15 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Intervention

Drug:
daily intranasal administration of insulin


Locations

Country Name City State
Finland Department of Pediatrics, University of Turku Turku

Sponsors (4)

Lead Sponsor Collaborator
University of Turku Helsinki University, Oulu University Hospital, University of Tampere

Country where clinical trial is conducted

Finland, 

References & Publications (5)

Hermann R, Mantere J, Lipponen K, Veijola R, Soltesz G, Otonkoski T, Simell O, Knip M, Ilonen J. Lack of association of PAX4 gene with type 1 diabetes in the Finnish and Hungarian populations. Diabetes. 2005 Sep;54(9):2816-9. — View Citation

Keskinen P, Korhonen S, Kupila A, Veijola R, Erkkilä S, Savolainen H, Arvilommi P, Simell T, Ilonen J, Knip M, Simell O. First-phase insulin response in young healthy children at genetic and immunological risk for Type I diabetes. Diabetologia. 2002 Dec;45(12):1639-48. Epub 2002 Oct 30. — View Citation

Kukko M, Toivonen A, Kupila A, Korhonen S, Keskinen P, Veijola R, Virtanen SM, Ilonen J, Simell O, Knip M. Familial clustering of beta-cell autoimmunity in initially non-diabetic children. Diabetes Metab Res Rev. 2006 Jan-Feb;22(1):53-8. — View Citation

Kupila A, Keskinen P, Simell T, Erkkilä S, Arvilommi P, Korhonen S, Kimpimäki T, Sjöroos M, Ronkainen M, Ilonen J, Knip M, Simell O. Genetic risk determines the emergence of diabetes-associated autoantibodies in young children. Diabetes. 2002 Mar;51(3):646-51. — View Citation

Kupila A, Sipilä J, Keskinen P, Simell T, Knip M, Pulkki K, Simell O. Intranasally administered insulin intended for prevention of type 1 diabetes--a safety study in healthy adults. Diabetes Metab Res Rev. 2003 Sep-Oct;19(5):415-20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Development of clinical type 1 diabetes
Secondary Number and concentration in serum of diabetes-associated autoantibodies (ICA, IAA, GADA and IA-2A)
Secondary Responses to intravenous glucose tolerance test
Secondary Possible side effects of therapy including hypoglycemia
Secondary Changes in serum metabolite patterns (metabolomics)
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