| Trial ID: | L3291 |
| Source ID: | NCT01548235
|
| Associated Drug: |
Biphasic Insulin Aspart 30
|
| Title: |
Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting or Switching to Biphasic Insulin Aspart 30 Treatment
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: biphasic insulin aspart 30
|
| Outcome Measures: |
Primary: Incidence of SADR (serious adverse drug reactions) including major hypoglycaemia | Secondary: Change from baseline in HbA1c (glycosylated haemoglobin)|Mean FPG (fasting plasma glucose)|Overall, daytime and nocturnal frequency of hypoglycaemic events
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
423
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2006-02
|
| Completion Date: |
2007-04
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-06
|
| Locations: |
Novo Nordisk Investigational Site, Copenhagen S, 2300, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT01548235
|
