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| Sponsor: | Melbourne Health |
|---|---|
| Collaborator: |
Diabetes Vaccine Development Centre |
| Information provided by: | Melbourne Health |
| ClinicalTrials.gov Identifier: | NCT00336674 |
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 II |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Any defect or pathology of nasal passage which would preclude application of the intranasal spray.
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Contacts and Locations| Contact: Professor Leonard C Harrison, MD DSc FRACP | 61 3 9345 2461 | harrison@wehi.edu.au |
| 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 | |
| Principal Investigator: | Leonard C Harrison, MBBS MD DSc | Melbourne Health |
More Information
| 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 |
|
Type 1 diabetes |
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |