| Trial ID: | L5389 |
| Source ID: | NCT00709475
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
Observational Safety Study in Subjects Using LevemirĀ® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus
|
| Acronym: |
LevSafeQD
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin detemir
|
| Outcome Measures: |
Primary: Incidence of serious adverse drug reactions, evaluated via number of major hypoglycaemic events, For the duration of the study (32 weeks) | Secondary: Number of serious adverse events, For the duration of the study|Number of all adverse events, For the duration of the study|Number of all - daytime and nocturnal - hypoglycaemic events, In the 4 weeks before baseline compared to 4 weeks before interim and final visits|Weight changes compared to baseline, At the end of the study|HbA1c compared to baseline, At the end of the study|Fasting glucose level control compared to baseline as measured by FBG, After 16 and 32 weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
747
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2008-05
|
| Completion Date: |
2009-10
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-28
|
| Locations: |
Novo Nordisk Investigational Site, Riyadh, 3542, Saudi Arabia
|
| URL: |
https://clinicaltrials.gov/show/NCT00709475
|