| Trial ID: | L7358 |
| Source ID: | NCT00715351
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
Observational Study of Patients Using Levemir® or Insulatard® as Start Insulin for Treatment of Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin detemir|DRUG: insulin NPH
|
| Outcome Measures: |
Primary: Body weight change, at 3 months and 6 months after baseline | Secondary: Hypoglycemic events, at 3 months and 6 months after baseline|Changes in glycaemic parameters, at 3 months and 6 months after baseline|Safety parameters by collecting (serious) adverse events and the pregnancies., at 3 months and 6 months after baseline|Evaluation of general well-being by using the WHO-5 well-being questionnaire (Appendix I)., at 3 months and 6 months after baseline|Treatment satisfaction of subjects treated with insulin Levemir or NPH insulin by using insulin satisfaction ('Tevredenheid met insuline behandeling': Appendix II), at 3 months and 6 months after baseline|Satisfaction of physicians who treat the subjects with insulin Levemir or NPH in-sulin by using a scale of 0-10 (Appendix III)., at 3 months and 6 months after baseline|Changes in doses, at 3 months and 6 months after baseline|HbA1c, at 3 months and 6 months after baseline|Changes in daily blood glucose values, at 3 months and 6 months after baseline
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
342
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2007-05
|
| Completion Date: |
2008-07
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-25
|
| Locations: |
Novo Nordisk Investigational Site, Ljubljana, SI-1000, Slovenia
|
| URL: |
https://clinicaltrials.gov/show/NCT00715351
|
