| Trial ID: | L5867 |
| Source ID: | NCT01404676
|
| Associated Drug: |
Add Vildagliptin
|
| Title: |
The Effect of Vildagliptin Based Treatment Versus Sulfonylurea on Glycemic Variability, Oxidative Stress, GLP-1, and Endothelial Function in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Add Vildagliptin|DRUG: Add Glimepiride
|
| Outcome Measures: |
Primary: Change in mean amplitude of glycemic excursion(MAGE) for 12 weeks(12weeks - 0 week)., To compare the effect of vildagliptin based treatment for 12 weeks on glycemic variability with sulfonylurea using continuous glucose monitoring system(CGMS)., 0 week and 12 weeks | Secondary: Change from baseline in oxidative stress markers and inflammatory markers at 12 weeks. Change from baseline in endothelial cell function at 12 weeks., 1. To evaluate the change of oxidative stress markers and inflammatory markers from baseline. 2. To evaluate the change of endothelial cell function using high-resolution ultrasonography to measure brachial artery flow-mediated dilation (FMD) from baseline., 0 week and 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Samsung Medical Center | Collaborators: Novartis
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
34
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-06
|
| Completion Date: |
2012-05
|
| Results First Posted: |
|
| Last Update Posted: |
2018-09-18
|
| Locations: |
Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 135-710, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01404676
|
