| Trial ID: | L2029 |
| Source ID: | NCT01545791
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
Observational Study to Evaluate the Safety of Levemir® in Patients With Diabetes
|
| Acronym: |
PREDICTIVE™
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin detemir
|
| Outcome Measures: |
Primary: Number of serious adverse drug reactions (SADRs), including major hypoglycaemic events, Weeks 0-26 | Secondary: Number of serious adverse events (SAEs), Weeks 0-26|Number of all adverse events (AEs), Weeks 0-26|Number of all hypoglycaemic events, In the 4 weeks preceeding week 26|Weight change, Week 0, week 26|Glycosylated haemoglobin (HbA1c), Week 26|Variability in fasting plasma glucose (FPG), Week 26|Average plasma glucose level, Week 26|Quality of Life as assessed by a treatment satisfaction questionnaire, Week 26
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
1037
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2006-05
|
| Completion Date: |
2008-02
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-28
|
| Locations: |
Novo Nordisk Investigational Site, Dublin, DUBLIN 15, Ireland|Novo Nordisk Investigational Site, London, W12 OHS, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT01545791
|
