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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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 |
- 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).
- 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 ]
- 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.
| 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 |
Inclusion Criteria:
- Type 2 diabetic patients with A1C levels within the range 7% - 10%
Contacts and Locations| Contact: Moon-Kyu Lee | mk4132.lee@samsung.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 jaehyeonkim@paran.com | |
| Principal Investigator: Moon-Kyu Lee, MD, PhD | |
| 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 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Vildagliptin Metformin Hypoglycemic Agents Physiological Effects of Drugs |
Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013