Intranasal Insulin for Prevention of Type 1 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by University of Turku.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Oulu University Hospital
University of Tampere
Helsinki University
Information provided by:
University of Turku
ClinicalTrials.gov Identifier:
NCT00223613
First received: September 13, 2005
Last updated: September 18, 2006
Last verified: August 2005
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   1 Year to 15 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
Additional 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
Study First Received: September 13, 2005
Last Updated: September 18, 2006
Health Authority: Finland: Ethics Committee

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014