| Trial ID: | L5342 |
| Source ID: | NCT01076842
|
| Associated Drug: |
Insulin-Levemir
|
| Title: |
Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Type 2
|
| Interventions: |
DRUG: Insulin-Levemir|DRUG: Exenatide-Bayetta|DRUG: Insulin-Levemir and Exenatide-Bayetta|DEVICE: SenseWear Pro3® armband|DEVICE: DexCom CGM
|
| Outcome Measures: |
Primary: The primary endpoint is the improvement in A1C goal measured in mean reduction in A1c levels over 24 weeks., 1 month | Secondary: Hypoglycemia weight waist-hip ratio frequency of hypoglycemia weight FBGL lipid levels CBC CMP biometric parameters of activity heat flux galvanic skin response heart rate level of physical activity and energy expenditure, 1 month
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S | Collaborators: BodyMedia
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
75
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-04
|
| Completion Date: |
2011-04
|
| Results First Posted: |
|
| Last Update Posted: |
2011-06-27
|
| Locations: |
MedStar Research Institute, Washington, District of Columbia, 20003, United States|Walter Reed Army Medical Center, Washington, District of Columbia, 20306, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01076842
|
