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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01404676 |
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Date of registration:
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22/06/2010 |
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Primary sponsor: |
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Public title:
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The Effect of Vildagliptin Based Treatment Versus Sulfonylurea on Glycemic Variability, Oxidative Stress, GLP-1, and Endothelial Function in Patients With Type 2 Diabetes
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Scientific title:
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The Effect of Vildagliptin Based Treatment Versus Sulfonylurea on Glycemic Variability, Oxidative Stress, GLP-1, and Endothelial Function in Patients With Type 2 Diabetes |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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46 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01404676 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Jae Hyeon KIM, MD, PhD |
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Address:
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Telephone:
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82-2-3410-1580 |
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Email:
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jaehyeonkim@paran.com |
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Affiliation:
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Name:
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Moon-Kyu Lee |
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Address:
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Telephone:
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Email:
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mk4132.lee@samsung.com |
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Affiliation:
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Name:
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Moon-Kyu Lee |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Type 2 diabetic patients with A1C levels within the range 7% - 10%
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Intervention(s)
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Drug: Glimepiride and metformin
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Drug: Vildagliptin and metformin
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Primary Outcome(s)
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Change in mean amplitude of glycemic excursion(MAGE) for 12 weeks(12weeks - 0 week).
[Time Frame: 0 week and 12 weeks]
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Secondary Outcome(s)
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Change from baseline in oxidative stress markers and inflammatory markers at 12 weeks. Change from baseline in endothelial cell function at 12 weeks.
[Time Frame: 0 week and 12 weeks]
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Secondary ID(s)
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2010-02-053
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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