Intranasal Insulin for Prevention of Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

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)

External Links

•   Description of the entire DIPP study