| Trial ID: | L5526 |
| Source ID: | NCT00658099
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard®
|
| Acronym: |
EVIDENCE
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin detemir|DRUG: insulin NPH
|
| Outcome Measures: |
Primary: Change in weight, after 6 months of treatment | Secondary: The effect on metabolic control assessed by the changes in glycaemic parameters: HbA1c and blood glucose values, after 6 months of treatment|The incidence of hypoglycaemic events, after 6 months of treatment|Safety parameters by collecting (serious) adverse drug reactions, pregnancies and technical complaints., after 6 months of treatment|The general well-being by using the WHO-5 well-being questionnaire., after 6 months of treatment|The treatment satisfaction of subjects treated with insulin detemir or NPH insulin by using insulin treatment satisfaction questionnaire, after 6 months of treatment|The satisfaction of physicians who treat the subjects with either insulin detemir or NPH insulin by using 4 questions, which are included in CRF, at the final visit., after 6 months of treatment
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
699
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2007-11
|
| Completion Date: |
2008-06
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-31
|
| Locations: |
Novo Nordisk Investigational Site, Bucharest, 010031, Romania
|
| URL: |
https://clinicaltrials.gov/show/NCT00658099
|
