| Trial ID: | L4829 |
| Source ID: | NCT00701155
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
Observational Study to Evaluate the Safety While Using Levemir®
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin detemir
|
| Outcome Measures: |
Primary: Incidence of serious ADRs incl. major hypoglycemias, after 24 weeks | Secondary: Number of serious adverse events, after 24 weeks|Number of all adverse events, after 24 weeks|Weight changes, after 24 weeks|HbA1c, after 24 weeks|Subgroup analysis of hypoglycemias, after 24 weeks|Number of all hypoglycemic events, in the 4 weeks preceding the visits at 12 weeks and 24 weeks.|Variability in fasting Blood Sugar and average plasma glucose levels, after 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
3593
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2007-07
|
| Completion Date: |
2008-03
|
| Results First Posted: |
|
| Last Update Posted: |
2023-11-02
|
| Locations: |
Giza, 0020, Egypt
|
| URL: |
https://clinicaltrials.gov/show/NCT00701155
|
