| Trial ID: | L6582 |
| Source ID: | NCT00789711
|
| Associated Drug: |
Biphasic Insulin Aspart 30
|
| Title: |
An Observational Study to Compare the Safety and Effectiveness of NovoMix® 30 and Levemir™ for the Treatment of Diabetes
|
| Acronym: |
SAFE
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: biphasic insulin aspart 30|DRUG: insulin detemir
|
| Outcome Measures: |
Primary: Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions., during 12 months of treatment | Secondary: HbA1c, at the end of the study|FBG (Fasting Blood Glucose), at the end of the study|Average (mean) fasting plasma glucose level, at the end of the study|Number of minor (including nocturnal) hypoglycaemic events, during 12 months of treatment|Number of major (including nocturnal) hypoglycaemic events, during 12 months of treatment
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
3131
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2008-11
|
| Completion Date: |
2009-08
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-31
|
| Locations: |
Novo Nordisk Investigational Site, Manilla, 1605, Philippines
|
| URL: |
https://clinicaltrials.gov/show/NCT00789711
|
