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| Tracking Information | |||||
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| First Received Date ICMJE | June 12, 2006 | ||||
| Last Updated Date | March 8, 2007 | ||||
| Start Date ICMJE | December 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Diagnosis of Diabetes AT 5 years according to ADA/WHO criteria. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00336674 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Trial of Intranasal Insulin in Children and Young Adults at Risk of Type 1 Diabetes | ||||
| Official Title ICMJE | A Randomised, Double-Blind, Placebo-Controlled Trial of Intranasal Insulin (1.6mg and 16mg) in Children and Young Adults at Risk of Type 1 Diabetes: Intranasal Insulin Trial II | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Type 1 Diabetes | ||||
| Intervention ICMJE | Biological: Intranasal insulin | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 264 | ||||
| Completion Date | December 2012 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 4 Years to 30 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Australia | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00336674 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | INIT II | ||||
| Study Sponsor ICMJE | Melbourne Health | ||||
| Collaborators ICMJE | Diabetes Vaccine Development Centre | ||||
| Investigators ICMJE |
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| Information Provided By | Melbourne Health | ||||
| Verification Date | January 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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