| Trial ID: | L4572 |
| Source ID: | NCT00223613
|
| Associated Drug: |
Daily Intranasal Administration Of Insulin
|
| Title: |
Intranasal Insulin for Prevention of Type 1 Diabetes
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: daily intranasal administration of insulin
|
| Outcome Measures: |
Primary: Development of clinical type 1 diabetes | Secondary: 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)
|
| Sponsor/Collaborators: |
Sponsor: University of Turku | Collaborators: Oulu University Hospital|Tampere University|University of Helsinki
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE3
|
| Enrollment: |
240
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: PREVENTION
|
| Start Date: |
1997-08
|
| Completion Date: |
2005-08
|
| Results First Posted: |
|
| Last Update Posted: |
2006-09-19
|
| Locations: |
Department of Pediatrics, University of Turku, Turku, FI-20520, Finland
|
| URL: |
https://clinicaltrials.gov/show/NCT00223613
|
