| Trial ID: | L6106 |
| Source ID: | NCT00656422
|
| Associated Drug: |
Insulin Levemir
|
| Title: |
Weight Gain, Eating Patterns, and Development of Body Composition During Initiation of Basal Insulin Therapy in Patients With Type 2 Diabetes: A Comparison of Insulin Detemir and Insulin Glargine
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Obesity
|
| Interventions: |
DRUG: insulin Levemir|DRUG: insulin Lantus
|
| Outcome Measures: |
Primary: To describe changes in hepatic fat content between groups., week 26, week 52 | Secondary: To describe the weight changes from baseline to month 12 between the groups following a subcutaneous treatment strategy with either insulin detemir or insulin glargine., week 26, week 52|To evaluate changes in body fat and visceral adipose tissue between groups., week 26, week 52|To describe changes in waist and hip circumferences between groups., weel 26, week 52|To describe changes in eating behavior and food selection between groups., week 26, week 52|To describe changes in well being and disease perception between groups., week 26, week 52|To evaluate the daily insulin dose between groups., 1 year|To describe the fasting blood glucose between groups., 1 year|To evaluate hypoglycaemia between groups., 1 year|To evaluate safety between groups., 1 year
|
| Sponsor/Collaborators: |
Sponsor: University Hospital Tuebingen | Collaborators: Medical University of Vienna|University of Bern|CenTrial GmbH
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
66
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
|
| Start Date: |
2007-11
|
| Completion Date: |
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| Results First Posted: |
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| Last Update Posted: |
2012-11-01
|
| Locations: |
Medical University Graz, Graz, 8036, Austria|University Hospital Graz, Graz, 8036, Austria|Medical University Vienna, Vienna, 1090, Austria|University Hospital of Tübingen, Tübingen, 72076, Germany|University Hospital, Bern, 3010, Switzerland
|
| URL: |
https://clinicaltrials.gov/show/NCT00656422
|
