| Trial ID: | L5883 |
| Source ID: | NCT01542476
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
The Impact of Initiating/Switching to Insulin Detemir on Emotional Well-being and Treatment Satisfaction
|
| Acronym: |
CONFIDENCE
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin detemir
|
| Outcome Measures: |
Primary: Change in Patient-Reported Outcomes (PRO) using World Health Organization 5 (WHO-5) item Well-being Index: Insulin Treatment Appraisal Scale (ITAS), Baseline, month 6 | Secondary: Change in Patient-Reported Outcomes (PRO) using Insulin Treatment (ITSQ), Baseline, month 6|Change in HbA1c (glycosylated haemoglobin), Baseline, month 6|Change in Fasting blood glucose (FBG), Baseline, month 6|Change in body weight, Baseline, month 6|Hypoglycaemic episodes, Month 6|Adverse events, Month 6
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
299
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2006-08
|
| Completion Date: |
2007-10
|
| Results First Posted: |
|
| Last Update Posted: |
2016-03-03
|
| Locations: |
Alphen a/d Rijn, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT01542476
|
