| Trial ID: | L4398 |
| Source ID: | NCT00775736
|
| Associated Drug: |
Biphasic Insulin Aspart 30
|
| Title: |
Observational Study Evaluating the Safety of NovoMix® in Type 2 Diabetes Patients Previously Treated With a Human Premix Insulin
|
| Acronym: |
Mix2Mix
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: biphasic insulin aspart 30|DRUG: biphasic insulin aspart 50|DRUG: biphasic insulin aspart 70
|
| Outcome Measures: |
Primary: The number of serious adverse drug reactions, including major hypoglycaemic episodes, reported during the study period., At baseline, 12 and 26 weeks. | Secondary: Number of all hypoglycaemic episodes., At baseline, 12 and 26 weeks.|Number of all adverse drug reactions., At baseline, 12 and 26 weeks.|HbA1c, at 12 and 26 weeks|Evaluation of fasting plasma glucose (FPG) values and postprandial glucose (PPG) levels, at 12 and 26 weeks|Weight changes, at 12 and 26 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
611
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2008-10
|
| Completion Date: |
2011-01
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-11
|
| Locations: |
Novo Nordisk Investigational Site, Brussels, 1070, Belgium|Novo Nordisk Investigational Site, Luxembourg, Luxembourg
|
| URL: |
https://clinicaltrials.gov/show/NCT00775736
|
