The Effect of Vildagliptin Based Treatment Versus Sulfonylurea on Glycemic Variability, Oxidative Stress, GLP-1, and Endothelial Function in Patients With Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01404676
First received: June 22, 2010
Last updated: July 27, 2011
Last verified: July 2011

June 22, 2010
July 27, 2011
June 2010
May 2012   (final data collection date for primary outcome measure)
Change in mean amplitude of glycemic excursion(MAGE) for 12 weeks(12weeks - 0 week). [ Time Frame: 0 week and 12 weeks ] [ Designated as safety issue: No ]
To compare the effect of vildagliptin based treatment for 12 weeks on glycemic variability with sulfonylurea using continuous glucose monitoring system(CGMS).
Same as current
Complete list of historical versions of study NCT01404676 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
  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.
Same as current
Not Provided
Not Provided
 
The Effect of Vildagliptin Based Treatment Versus Sulfonylurea on Glycemic Variability, Oxidative Stress, GLP-1, and Endothelial Function in Patients With Type 2 Diabetes
The Effect of Vildagliptin Based Treatment Versus Sulfonylurea on Glycemic Variability, Oxidative Stress, GLP-1, and Endothelial Function in Patients With Type 2 Diabetes

The effect of vildagliptin based treatment versus sulfonylurea based treatment on glycemic variability, oxidative stress, and endothelial function in patients with type 2 diabetes.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Type 2 Diabetes Mellitus
  • Drug: Vildagliptin and metformin
    Effects on glycemic variability, oxidative stress, and endothelial cell function.
  • Drug: Glimepiride and metformin
    Effects on glycemic variability, oxidative stress,and endothelial cell function.
  • Experimental: Vildagliptin, metformin
    groupA:Vildagliptin 50 mg bid + Metformin 500-1000mg bid q day.
    Intervention: Drug: Vildagliptin and metformin
  • Active Comparator: glimepiride, metformin
    groupB:Glimepiride 2 mg + Metformin 500-1000 mg bid q day.
    Intervention: Drug: Glimepiride and metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
46
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetic patients with A1C levels within the range 7% - 10%
Both
18 Years to 70 Years
No
Contact: Moon-Kyu Lee mk4132.lee@samsung.com
Korea, Republic of
 
NCT01404676
2010-02-053
Yes
Moon-Kyu Lee. MD, PhD, Division of Endocrinology and Metabolism, Department of Internal Medicine,Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Moon-Kyu Lee Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Samsung Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP