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Completed

NCT Number: NCT01404676

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetic patients with hemoglobin A1c levels within the range 7% - 10%

Treatment and study plan

Add Vildagliptin

Drug

Adding Vildagliptin 50 mg bid to patients with type 2 diabetes mellitus being treated with metformin 500-1000mg bid per day who had hemoglobin A1c of 7.0-10.0%

Add Glimepiride

Drug

Adding Glimepiride 2mg to patients with type 2 diabetes mellitus being treated with metformin 500-1000mg bid per day who had hemoglobin A1c of 7.0-10.0%

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Novartis

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 28, 2011
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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