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
  Purpose

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


Condition Intervention
Type 2 Diabetes Mellitus
Drug: Vildagliptin and metformin
Drug: Glimepiride and metformin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 46
Study Start Date: June 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetic patients with A1C levels within the range 7% - 10%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404676

Contacts
Contact: Moon-Kyu Lee mk4132.lee@samsung.com

Locations
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    jaehyeonkim@paran.com   
Principal Investigator: Moon-Kyu Lee, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Moon-Kyu Lee Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
  More Information

No publications provided

Responsible Party: Moon-Kyu Lee. MD, PhD, Division of Endocrinology and Metabolism, Department of Internal Medicine,Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01404676     History of Changes
Other Study ID Numbers: 2010-02-053
Study First Received: June 22, 2010
Last Updated: July 27, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
Glucose variability
Oxidative stress
Endothelial cell function

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Vildagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014