AzTrials
AzTrials

Type 1 DiabetesPhase 3NCT00223613

Intranasal Insulin for Prevention of Type 1 Diabetes

A Phase 3 study testing daily intranasal administration of insulin in people with Type 1 Diabetes, run by University of Turku at 1 site in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 1 year to 15 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes
What is being tested?
daily intranasal administration of insulin
How many people
240 participants
Where
1 siteFinland
Study dates
Aug 1997to Aug 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • severe other disease
  • age above 15 years

Trial locations and contacts

1 site in 1 country.

Olli G Simell, MD, PhD contact

+358-2-313-2466

olli.simell@utu.fi

Tuula T Simell, MPH, PhD contact

+358-2-313-3427

tuula.simell@utu.fi

Finland1 site, 1 recruiting

  • Department of Pediatrics, University of Turku

    Turku, FI-20520

    Tuula T Simell, MPH, PhD, +358-2-313-3427, tuula.simell@utu.fi

    Birgitta Nurmi, RN, +358-2-313-2465, birgitta.nurmi@tyks.fi

    Recruiting

Other trials in Finland

About this study

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

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.

Read the 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
Being tested
daily intranasal administration of insulin
Keywords
diabetes, juvenile diabetes, insulin deficiency
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • daily intranasal administration of insulinDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Development of clinical type 1 diabetes

Secondary outcomes (4)

  1. Number and concentration in serum of diabetes-associated autoantibodies (ICA, IAA, GADA and IA-2A)

  2. Responses to intravenous glucose tolerance test

  3. Possible side effects of therapy including hypoglycemia

  4. Changes in serum metabolite patterns (metabolomics)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startAug 1997
  3. Study completionAug 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
240 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00223613
Sponsor's protocol ID
DIPP19942014
Other IDs
JDRF File # 4-1999-731
Status last verified
Aug 2005
First submitted
13 Sep 2005
Last updated
19 Sep 2006
Results posted
No

Publications

  • 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.

    PubMed 12951650

  • 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.

    PubMed 12488953

  • 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.

    PubMed 11872662

  • 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.

    PubMed 16123375

  • 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.

    PubMed 16100734

  • 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.

    PubMed 22237062

  • 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.

    PubMed 19752173

  • 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.

    PubMed 18814906

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing daily intranasal administration of insulin in people with Type 1 Diabetes, run by University of Turku at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Olli G Simell, MD, PhD (+358-2-313-2466, olli.simell@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Development of clinical type 1 diabetes. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00223613, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2006.

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