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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Insulin-Dependent
Biological: Intranasal insulin
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • Diagnosis of Diabetes AT 5 years according to ADA/WHO criteria.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 120
Study Start Date: December 2006
Estimated Study Completion Date: December 2016
Arms Assigned Interventions
Active Comparator: 1 Biological: Intranasal insulin
Placebo Comparator: 2 Other: Placebo

  Eligibility

Ages Eligible for Study:   4 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

    -

  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: NCT00336674

Contacts
Contact: Professor Leonard C Harrison, MD DSc FRACP 61 3 9345 2461 harrison@wehi.edu.au

Locations
Australia, Australian Capital Territory
Canberra Hospital Recruiting
Canberra, Australian Capital Territory, Australia, 2606
Principal Investigator: Tony Lafferty         
Australia, New South Wales
Royal North Shore Hospital Recruiting
St Leonards, New South Wales, Australia, 2065
Principal Investigator: Michelle Jack         
Sub-Investigator: Greg Fulcher         
The Children's Hospital at Westmead Recruiting
Westmead, New South Wales, Australia, 2145
Principal Investigator: Kim Donaghue         
Australia, Queensland
Mater Children's Hospital Recruiting
Brisbane, Queensland, Australia, 4101
Principal Investigator: Andrew Cotterill         
Sub-Investigator: Mark Harris         
Sub-Investigator: Ristan Green         
Australia, South Australia
Womens and Childrens Hospital Recruiting
North Adelaide, South Australia, Australia, 5006
Principal Investigator: Jennifer Couper         
Australia, Victoria
Royal Melbourne Hospital Recruiting
Melbourne, Victoria, Australia, 3050
Principal Investigator: Leonard C Harrison, MD DSc FRACP         
Principal Investigator: Peter Colman         
Royal Children's Hospital Recruiting
Melbourne, Victoria, Australia, 3052
Contact: Fergus Cameron         
Principal Investigator: Prof Fergus Cameron         
Australia, Western Australia
Princess Margaret Hospital Recruiting
Subiaco, Western Australia, Australia, 6840
Principal Investigator: Tim Jones         
Sub-Investigator: Elizabeth Davis         
New Zealand
University of Auckland Recruiting
Auckland, New Zealand
Principal Investigator: Craig Jefferies         
Christchurch Hospital Recruiting
Christchurch, New Zealand
Principal Investigator: Russell Scott         
Sub-Investigator: Brian Darlow         
Sub-Investigator: Jinny Willis         
Sponsors and Collaborators
Melbourne Health
Diabetes Vaccine Development Centre
Investigators
Principal Investigator: Leonard C Harrison, MBBS MD DSc Melbourne Health
  More Information

No publications provided

Responsible Party: Executive Director of Research, Melbourne Health
ClinicalTrials.gov Identifier: NCT00336674     History of Changes
Other Study ID Numbers: INIT II
Study First Received: June 12, 2006
Last Updated: February 20, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Melbourne Health:
Type 1 diabetes

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 22, 2014