Type 2 Diabetes Mellitus
Conditions
Keywords
Glucose variability, Oxidative stress, Endothelial cell function
Brief summary
The effect of vildagliptin based treatment versus sulfonylurea based treatment on glycemic variability, oxidative stress, and endothelial function in patients with type 2 diabetes.
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.
Interventions
DRUGAdd Vildagliptin
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%
DRUGAdd Glimepiride
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%
Sponsors
Novartis
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetic patients with hemoglobin A1c levels within the range 7% - 10%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean amplitude of glycemic excursion(MAGE) for 12 weeks(12weeks - 0 week). | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in oxidative stress markers and inflammatory markers at 12 weeks. Change from baseline in endothelial cell function at 12 weeks. | 0 week and 12 weeks | 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. |
Countries
South Korea
Outcome results
None listed