| Trial ID: | L6453 |
| Source ID: | NCT00709683
|
| Associated Drug: |
Biphasic Insulin Aspart 30
|
| Title: |
Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: biphasic insulin aspart 30
|
| Outcome Measures: |
Primary: Incidence of major hypoglycaemic events reported as serious adverse drug reactions, during 26 weeks of treatment | Secondary: Number of serious adverse drug reactions, during 26 weeks of treatment|Number of serious adverse events, during 26 weeks of treatment|Number of all major (daytime and nocturnal) hypoglycaemic events, during 26 weeks of treatment|Number of all minor (daytime and nocturnal) hypoglycaemic events, during 26 weeks of treatment|Weight (BMI) change from baseline, At the end of the study|HbA1c change from baseline, At the end of the study|Percentage of patients reaching the target of HbA1c of less than or equal to 7.0%, At the end of the study|Average (mean) fasting plasma glucose level, At the end of the study|Average post-breakfast (90-120 mins), post-lunch (90-120 mins), post-dinner (90-120 mins) plasma glucose level, At the end of the study
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
216
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2008-05
|
| Completion Date: |
2009-05
|
| Results First Posted: |
|
| Last Update Posted: |
2016-03-07
|
| Locations: |
Tunisia, 1053, Tunisia
|
| URL: |
https://clinicaltrials.gov/show/NCT00709683
|
