| Trial ID: | L6969 |
| Source ID: | NCT00675493
|
| Associated Drug: |
Biphasic Insulin Aspart 30
|
| Title: |
Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix®30
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: biphasic insulin aspart 30
|
| Outcome Measures: |
Primary: Change in HbA1c from baseline, For the duration of the study | Secondary: Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%, after 12 weeks and 24 weeks of treatment|Change in FPG (glucose variability), after 12 weeks and 24 weeks of treatment|Change in PPG (postprandial control), after 12 weeks and 24 weeks of treatment|Change in insulin dose and number of injections, at 12 weeks and 24 weeks of treatment|Change in oral antidiabetic drug therapy, after 12 weeks and 24 weeks of treatment|Change in body weight, at 12 weeks and 24 weeks of treatment|Change in number of hypoglycaemic events, during 4 weeks proceeding routine visits at 12 weeks and 24 weeks of treatment|Number of adverse drug reactions (ADR), after 12 weeks and 24 weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
942
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2008-05
|
| Completion Date: |
2009-01
|
| Results First Posted: |
|
| Last Update Posted: |
2016-02-19
|
| Locations: |
Bucharest, 010031, Romania
|
| URL: |
https://clinicaltrials.gov/show/NCT00675493
|
