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Intranasal Insulin for Prevention of Type 1 Diabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2005 by University of Turku.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00223613
First Posted: September 22, 2005
Last Update Posted: September 19, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Oulu University Hospital
University of Tampere
Helsinki University
Information provided by:
University of Turku
  Purpose
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.

Condition Intervention Phase
Type 1 Diabetes Drug: daily intranasal administration of insulin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Intranasal Insulin for Prevention of Type 1 Diabetes in Children Carrying Increased HLA-Conferred Genetic Risk

Resource links provided by NLM:


Further study details as provided by University of Turku:

Primary Outcome Measures:
  • Development of clinical type 1 diabetes

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 240
Study Start Date: August 1997
Estimated Study Completion Date: August 2005
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223613


Contacts
Contact: Olli G Simell, MD, PhD +358-2-313-2466 olli.simell@utu.fi
Contact: Tuula T Simell, MPH, PhD +358-2-313-3427 tuula.simell@utu.fi

Locations
Finland
Department of Pediatrics, University of Turku Recruiting
Turku, Finland, FI-20520
Contact: Tuula T Simell, MPH, PhD    +358-2-313-3427    tuula.simell@utu.fi   
Contact: Birgitta Nurmi, RN    +358-2-313-2465    birgitta.nurmi@tyks.fi   
Sub-Investigator: Kirsti Näntö-Salonen, MD, PhD         
Sponsors and Collaborators
University of Turku
Oulu University Hospital
University of Tampere
Helsinki University
Investigators
Principal Investigator: Olli G Simell, MD, PhD University of Turku, Turku, Finland
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00223613     History of Changes
Other Study ID Numbers: DIPP19942014
JDRF File # 4-1999-731
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: September 19, 2006
Last Verified: August 2005

Keywords provided by University of Turku:
diabetes
juvenile diabetes
insulin deficiency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs