| Trial ID: | L2614 |
| Source ID: | NCT00842192
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
An Observational Study in Type 2 Diabetic Patients on Oral Antidiabetic Drugs and Basal Insulin in Near East Countries
|
| Acronym: |
BO2NE
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin detemir
|
| Outcome Measures: |
Primary: Change in number of hypoglycaemic events from baseline, at 12 and 24 weeks|HbA1c, at 12 and 24 weeks | Secondary: Percentage of subjects to reach HbA1c between 6.5 and 7.0%, at 12 and 24 weeks|Glucose variability as measured by FPG, at 12 and 24 weeks|Postprandial glycaemic control as measured by PPG, at 12 and 24 weeks|Insulin dose and number of injections, at 12 and 24 weeks|Body weight, at 12 and 24 weeks|Number of adverse drug reactions (ADR), at 12 and 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
2155
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2009-04
|
| Completion Date: |
2010-08
|
| Results First Posted: |
|
| Last Update Posted: |
2016-12-07
|
| Locations: |
Novo Nordisk Investigational Site, Kfar Saba, 44425, Israel|Novo Nordisk Investigational Site, Amman, 11844, Jordan|Novo Nordisk Investigational Site, Amman, 11844, Lebanon|Novo Nordisk Investigational Site, Karachi, Pakistan
|
| URL: |
https://clinicaltrials.gov/show/NCT00842192
|
