The Effect of Vildagliptin Based Treatment Versus Sulfonylurea on Glycemic Variability, Oxidative Stress, GLP-1, and Endothelial Function in Patients With Type 2 Diabetes
|ClinicalTrials.gov Identifier: NCT01404676|
Recruitment Status : Unknown
Verified July 2011 by Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : July 28, 2011
Last Update Posted : July 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Vildagliptin and metformin Drug: Glimepiride and metformin||Not Applicable|
Recently, improved understanding of the incretin effect on the pathophysiology of type 2 diabetes has led to development of new agent for hypoglycemic therapy. Vildagliptin is a potent and highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor that augments the active glucagon-like peptide(GLP)-1 concentration, increases insulin secretion and improves glucose tolerance. Vildagliptin has a similar glucose lowering effect, but lower hypoglycemic events, as compared to glimepiride. Vildagliptin could improve not only the mean glycemic control but also 24 hour glycemic fluctuation by restoring the physiologic pattern of insulin and glucagon secretion. Furthermore, decreased postprandial glycemic excursion might reduce the oxidative stress markers and improve endothelial dysfunction. Those effects might be amplified in Asian patients because of prominent early phase insulin secretory defects accompanied with relatively less degree of insulin resistance. In addition, GLP-1 and GLP-1 analogues exert direct beneficial effects on endothelium-dependent vasodilatation. Therefore DPP-4 inhibitors may directly improve endothelial dysfunction.
Based on this assumption, this research will focus on the effect of vildagliptin on glycemic variability, oxidative stress markers and endothelial cell function compared to long acting sulfonylurea glimepiride in type 2 diabetic patients with inadequate glycemic control on metformin.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||May 2012|
Experimental: Vildagliptin, metformin
groupA:Vildagliptin 50 mg bid + Metformin 500-1000mg bid q day.
Drug: Vildagliptin and metformin
Effects on glycemic variability, oxidative stress, and endothelial cell function.
Active Comparator: glimepiride, metformin
groupB:Glimepiride 2 mg + Metformin 500-1000 mg bid q day.
Drug: Glimepiride and metformin
Effects on glycemic variability, oxidative stress,and endothelial cell function.
- Change in mean amplitude of glycemic excursion(MAGE) for 12 weeks(12weeks - 0 week). [ Time Frame: 0 week and 12 weeks ]To compare the effect of vildagliptin based treatment for 12 weeks on glycemic variability with sulfonylurea using continuous glucose monitoring system(CGMS).
- 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 ]
- To evaluate the change of oxidative stress markers and inflammatory markers from baseline.
- To evaluate the change of endothelial cell function using high-resolution ultrasonography to measure brachial artery flow-mediated dilation (FMD) from baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404676
|Contact: Moon-Kyu Leeemail@example.com|
|Korea, Republic of|
|Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Jae Hyeon KIM, MD, PhD 82-2-3410-1580 firstname.lastname@example.org|
|Principal Investigator: Moon-Kyu Lee, MD, PhD|
|Principal Investigator:||Moon-Kyu Lee||Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine|