| Trial ID: | L2007 |
| Source ID: | NCT00737776
|
| Associated Drug: |
Biphasic Insulin Aspart 30
|
| Title: |
Observational Study on Efficacy and Safety in Patients Using NovoMix® 30 for the Treatment of Diabetes
|
| Acronym: |
UPGRADE
|
| 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: HbA1c change, at the end of study after 26 weeks | Secondary: Number of serious adverse drug reactions, during the study|Number of serious adverse events, during the study|Number of all major (daytime and nocturnal) hypoglycaemic events, during the study|Number of major hypoglycaemic events related to omission of a meal after NovoMix® 30 injection, during the study|Number of major hypoglycaemic events related to physical exercise of at least 30 min, during the study|Number of all minor (daytime and nocturnal) hypoglycaemic events, during the study|Weight (BMI) change, at the end of study after 26 weeks|Lipid profile (Total cholesterol, LDL, HDL, Triglyceride) change, at the end of study after 26 weeks|Percentage of patients reaching the target of HbA1c below or equal to 6.5%, at the end of study after 26 weeks|Percentage of patients reaching the target of HbA1c below or equal to 7.0%, at the end of study after 26 weeks|Percentage of patients reaching the physician's own target recommendation, at the end of study after 26 weeks|Variability in fasting plasma glucose values and average (mean) fasting plasma glucose level, at the end of study after 26 weeks|Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) plasma glucose level, at the end of study after 26 weeks|Diabetes Fear of Self-Injection Questionnaire (D-FISQ), at the end of study after 26 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
1068
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2008-05
|
| Completion Date: |
2010-01
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-31
|
| Locations: |
Novo Nordisk Investigational Site, Seoul, 137-920, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT00737776
|
