| Trial ID: | L5322 |
| Source ID: | NCT00849342
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
Observational Study on Levemir® in Obese Diabetic Patients
|
| Acronym: |
KILOS
|
| 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 body weight and BMI, during 12 months of treatment | Secondary: Change in body weight at different BMI subgroups, at insulin start, 12 and 6 months before treatment and after 3, 6, 9 and 12 months of treatment|Change in waist perimeter, from insulin start and after 6 and 12 months of treatment|Change in FPG (Fasting Plasma Glucose), from 12 and 6 months before treatment after 6 and 12 months of treatment|Change in HbA1C, from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment|Change in number of hypoglycaemic events during 4 weeks proceeding routine visits, after 6 and 12 months of treatment|Number of adverse drug reactions (ADR), after 6 and 12 months of treatment|Change in blood pressure, from insulin start and 6 and 12 months after treatment
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
580
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2008-12
|
| Completion Date: |
2013-01
|
| Results First Posted: |
|
| Last Update Posted: |
2014-08-15
|
| Locations: |
Alphen a/d Rijn, Netherlands|Ljubljana, SI-1000, Slovenia
|
| URL: |
https://clinicaltrials.gov/show/NCT00849342
|
