| Trial ID: | L2387 |
| Source ID: | NCT00700765
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
Observational Study to Evaluate Safety of Levemir® in Type 1 and Type 2 Diabetes
|
| 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 adverse drug reactions (SADRs), during treatment|Major hypoglycaemic events, during treatment | Secondary: Number of serious adverse events, during treatment|Number of all adverse events, during treatment|Number of all hypoglycaemic events, the last 4 weeks of treatment|Weight changes, after 12 weeks|HbA1c, after 12 weeks and 26 weeks of treatment|Variability in fasting blood glucose (FBG) and average plasma glucose level, after 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
1531
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2008-01
|
| Completion Date: |
2008-07
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-28
|
| Locations: |
Novo Nordisk Investigational Site, Jakarta, 12520, Indonesia
|
| URL: |
https://clinicaltrials.gov/show/NCT00700765
|
