Intranasal Insulin for Prevention of Type 1 Diabetes

September 18, 2006 updated by: University of Turku

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
      • Turku, Finland, FI-20520
        • Recruiting
        • Department of Pediatrics, University of Turku
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Kirsti Näntö-Salonen, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Development of clinical type 1 diabetes

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Collaborators

Oulu University Hospital
University of Helsinki
Tampere University

Investigators

  • Principal Investigator: Olli G Simell, MD, PhD, University of Turku, Turku, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1997

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 19, 2006

Last Update Submitted That Met QC Criteria

September 18, 2006

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIPP19942014
  • JDRF File # 4-1999-731

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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