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Intranasal Insulin for Prevention of Type 1 Diabetes

NCT ID: NCT00223613

Last Updated: 2006-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-08-31

Study Completion Date

2005-08-31

Brief Summary

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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

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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

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Type 1 Diabetes

Keywords

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diabetes juvenile diabetes insulin deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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daily intranasal administration of insulin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oulu University Hospital

OTHER

Sponsor Role collaborator

Tampere University

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role lead

Principal Investigators

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Olli G Simell, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Turku, Turku, Finland

Locations

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Department of Pediatrics, University of Turku

Turku, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Olli G Simell, MD, PhD

Role: CONTACT

Phone: +358-2-313-2466

Email: [email protected]

Tuula T Simell, MPH, PhD

Role: CONTACT

Phone: +358-2-313-3427

Email: [email protected]

Facility Contacts

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Tuula T Simell, MPH, PhD

Role: primary

Birgitta Nurmi, RN

Role: backup

References

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Kupila A, Sipila 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. doi: 10.1002/dmrr.397.

Reference Type BACKGROUND
PMID: 12951650 (View on PubMed)

Keskinen P, Korhonen S, Kupila A, Veijola R, Erkkila 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. doi: 10.1007/s00125-002-0981-8. Epub 2002 Oct 30.

Reference Type BACKGROUND
PMID: 12488953 (View on PubMed)

Kupila A, Keskinen P, Simell T, Erkkila S, Arvilommi P, Korhonen S, Kimpimaki T, Sjoroos 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. doi: 10.2337/diabetes.51.3.646.

Reference Type BACKGROUND
PMID: 11872662 (View on PubMed)

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. doi: 10.2337/diabetes.54.9.2816.

Reference Type BACKGROUND
PMID: 16123375 (View on PubMed)

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. doi: 10.1002/dmrr.584.

Reference Type BACKGROUND
PMID: 16100734 (View on PubMed)

Virtanen SM, Nevalainen J, Kronberg-Kippila C, Ahonen S, Tapanainen H, Uusitalo L, Takkinen HM, Niinisto S, Ovaskainen ML, Kenward MG, Veijola R, Ilonen J, Simell O, Knip M. Food consumption and advanced beta cell autoimmunity in young children with HLA-conferred susceptibility to type 1 diabetes: a nested case-control design. Am J Clin Nutr. 2012 Feb;95(2):471-8. doi: 10.3945/ajcn.111.018879. Epub 2012 Jan 11.

Reference Type DERIVED
PMID: 22237062 (View on PubMed)

Goldstein E, Hermann R, Renfors TJ, Nanto-Salonen KM, Korhonen T, Karkkainen M, Veijola RK, Knip M, Simell TT, Simell OG. From genetic risk awareness to overt type 1 diabetes: parental stress in a placebo-controlled prevention trial. Diabetes Care. 2009 Dec;32(12):2181-3. doi: 10.2337/dc09-0423. Epub 2009 Sep 14.

Reference Type DERIVED
PMID: 19752173 (View on PubMed)

Nanto-Salonen K, Kupila A, Simell S, Siljander H, Salonsaari T, Hekkala A, Korhonen S, Erkkola R, Sipila JI, Haavisto L, Siltala M, Tuominen J, Hakalax J, Hyoty H, Ilonen J, Veijola R, Simell T, Knip M, Simell O. Nasal insulin to prevent type 1 diabetes in children with HLA genotypes and autoantibodies conferring increased risk of disease: a double-blind, randomised controlled trial. Lancet. 2008 Nov 15;372(9651):1746-55. doi: 10.1016/S0140-6736(08)61309-4. Epub 2008 Sep 22.

Reference Type DERIVED
PMID: 18814906 (View on PubMed)

Other Identifiers

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JDRF File # 4-1999-731

Identifier Type: -

Identifier Source: secondary_id

DIPP19942014

Identifier Type: -

Identifier Source: org_study_id