| Trial ID: | L2468 |
| Source ID: | NCT00834262
|
| Associated Drug: |
Biphasic Insulin Aspart 30
|
| Title: |
Observational Study on Safety and Efficacy of Biphasic Insulin Aspart in Type 2 Diabetes Patients
|
| Acronym: |
|
| 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: Number of all hypoglycaemic episodes, during 13 weeks of treatment | Secondary: Number of adverse drug reactions, during 13 weeks of treatment|Number of adverse events, during 13 weeks of treatment|Number of all major hypoglycaemic (daytime and nocturnal) episodes, during 13 weeks of treatment|Number of all minor and symptomatic (daytime and nocturnal) hypoglycaemic episodes, during 13 weeks of treatment|Number of major hypoglycaemic episodes related to omission of a meal after injection, during 13 weeks of treatment|Number of major hypoglycaemic episodes related to physical exercise of at least 30 min duration, during 13 weeks of treatment|Weight (BMI) change, at the end of the study after 13 weeks of treatment|HbA1c change, at the end of the study after 13 weeks of treatment|Percentage of patients reaching the target of HbA1c of 7.0% or less, at the end of the study after 13 weeks of treatment|Variability in fasting blood glucose values and average (mean) fasting blood glucose level, at the end of the study after 13 weeks of treatment|Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) blood glucose level, at the end of the study after 13 weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
339
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2009-04
|
| Completion Date: |
2010-02
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-31
|
| Locations: |
Novo Nordisk Investigational Site, Kfar Saba, 44425, Israel
|
| URL: |
https://clinicaltrials.gov/show/NCT00834262
|
