Trial of Intranasal Insulin in Children and Young Adults at Risk of Type 1 Diabetes (INIT II)

This study is currently recruiting participants.
Verified February 2011 by Melbourne Health
Sponsor:
Collaborator:
Diabetes Vaccine Development Centre
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00336674
First received: June 12, 2006
Last updated: February 20, 2011
Last verified: February 2011

June 12, 2006
February 20, 2011
December 2006
Not Provided
Diagnosis of Diabetes AT 5 years according to ADA/WHO criteria.
Same as current
Complete list of historical versions of study NCT00336674 on ClinicalTrials.gov Archive Site
  • B cell function: measured as glucose and insulin responses in OGTT 6monthly.
  • Insulin Action: Insulin resistance measured by HOMA-R 6 monthly.
  • Immune function: measured by levels of circulating antibodies to insulin, GAD and IA-2 and T cell responses to proinsulin, denatured insulin, GAD and tetanus at 5 years.
  • B cell function: measured as FPIR yearly and
  • glucose and insulin responses in OGTT 6monthly.
  • Insulin Action: Insulin resistance measured by HOMA-R 6 monthly.
  • Immune function: measured by levels of circulating antibodies to insulin, GAD and IA-2 and T cell responses to proinsulin, denatured insulin, GAD and tetanus at 5 years.
Not Provided
Not Provided
 
Trial of Intranasal Insulin in Children and Young Adults at Risk of Type 1 Diabetes
A Randomised, Double-blind, Placebo-controlled Trial of Intranasal Insulin (440 IU) in Children and Young Adults at Risk of Type 1 Diabetes: Intranasal Insulin Trial II

In people with type I diabetes the beta cells of the pancreas no longer make insulin because the body's immune system has attacked and destroyed the beta cells. It is thought that exposure of the mucous membranes to insulin may cause act like a vaccine effect whereby protective immune cells are stimulated and these then counteract the "bad" immune cells that damage the beta cells. This study aims to determine if intranasal insulin can protect beta cells and stop progression to diabetes in individuals who are at risk.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Diabetes Mellitus, Insulin-Dependent
  • Biological: Intranasal insulin
  • Other: Placebo
  • Active Comparator: 1
    Intervention: Biological: Intranasal insulin
  • Placebo Comparator: 2
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2016
Not Provided

Inclusion Criteria:

  1. First-degree or second-degree relative of a person with T1D diagnosed before age 40.
  2. Age 4-30 years if first-degree relative; age 4-20 years if second-degree relative.
  3. Confirmed serum antibodies to two or more islet antigens.
  4. Normal oral glucose tolerance test (OGTT).
  5. FPIR at or above threshold - Primary Stratum - greater than or equal to 10th percentile for siblings, offspring and second-degree relatives of person with T1D (greater than or equal to 100uU/ml if aged 8 or more years OR greater than or equal to 60 uU/ml if aged less than 8) and greater than or equal to the 1st percentile for parents of someone with T1D (greater than ore equal to 60uU/ml). Secondary Stratum: Greater than or equal 1st percentile, less than 10th percentile for siblings, offspring and second-degree relatives of someone with T1D (greater than or equal to 50uU/ml less than 100 uU/ml if aged greater than or equal to 8 years or greater than or equal to 20 uU/ml less than 60uU/ml if aged less than 8 years)
  6. Provision of written consent. -

Exclusion Criteria:

  1. History of treatment with insulin or oral hypoglycemic agents
  2. Known diabetes by ADA/WHO criteria
  3. Pregnant or lactating or of child-bearing potential not using an adequate method of contraception
  4. Concomitant disease or treatment which may interfere with assessment or cause immunosuppression, as judged by the investigators.
  5. Uncorrected vitamin D deficiency
  6. Known alcohol or drug abuse, psychiatric or other condition that could be associated with poor compliance.
  7. Known liver disease, or persisting elevation of plasma AST or ALT levels.
  8. Impaired renal function
  9. Any defect or pathology of nasal passage which would preclude application of the intranasal spray.

    -

Both
4 Years to 30 Years
No
Contact: Professor Leonard C Harrison, MD DSc FRACP 61 3 9345 2461 harrison@wehi.edu.au
Australia,   New Zealand
 
NCT00336674
INIT II
Yes
Executive Director of Research, Melbourne Health
Melbourne Health
Diabetes Vaccine Development Centre
Principal Investigator: Leonard C Harrison, MBBS MD DSc Melbourne Health
Melbourne Health
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP