Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Glucose variability
Oxidative stress
Endothelial cell function
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2011-07-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Change in mean amplitude of glycemic excursion(MAGE) for 12 weeks(12weeks - 0 week).
timeFrame: 0 week and 12 weeks
Secondary outcomes:
measure: Change from baseline in oxidative stress markers and inflammatory markers at 12 weeks. Change from baseline in endothelial cell function at 12 weeks.
timeFrame: 0 week and 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Study officials:
affiliation: Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Moon-Kyu Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim G, Oh S, Jin SM, Hur KY, Kim JH, Lee MK. The efficacy and safety of adding either vildagliptin or glimepiride to ongoing metformin therapy in patients with type 2 diabetes mellitus. Expert Opin Pharmacother. 2017 Aug;18(12):1179-1186. doi: 10.1080/14656566.2017.1353080. Epub 2017 Jul 17.