| Trial ID: | L2532 |
| Source ID: | NCT00771680
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
Observational Study to Evaluate the Effectiveness and Safety of Levemir®, NovoMix® 30 and NovoRapid® in Insulin naïve Subjects With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin detemir|DRUG: biphasic insulin aspart 30|DRUG: insulin aspart
|
| Outcome Measures: |
Primary: HbA1c, at baseline visit and during 3, 6, 9 and 12 months|Serious adverse drug reactions including major hypoglycaemic events, during 12 months of treatment | Secondary: Number of serious adverse drug reactions, during 12 months of treatment|Number of all major (daytime and nocturnal) hypoglycaemic events, during 12 months of treatment|Number of all minor (daytime and nocturnal) hypoglycaemic events, During 4 weeks prior to each study visit|Weight (BMI) change, At 6 and 12 months|Variability in fasting blood glucose values and average (mean) fasting blood glucose level, At baseline visit and after 6 and 12 months treatment|Average post-prandial blood glucose level (2h after dinner), At baseline visit and after 6 and 12 months treatment|Quality of Life (QoL) as assessed by patient questionnaire, At baseline and the end of 6 and 12 months treatment
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
10408
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2008-10
|
| Completion Date: |
2010-07
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-28
|
| Locations: |
Novo Nordisk Investigational Site, Moscow, 119330, Russian Federation|Novo Nordisk Investigational Site, Kiev, 252030, Ukraine
|
| URL: |
https://clinicaltrials.gov/show/NCT00771680
|
