Effect of Dipeptidyl Peptidase-IV Inhibitor and Sulfonylurea on Glucose Variability and Oxidative Stress

Study Overview
=================
Brief Summary
-----------------
This research will focus on the effect of Sitagliptin on 24 hour glycemic excursion and improvement of oxidative stress markers compared to long acting sulphonylurea Glimepiride in type 2 diabetic patients with inadequate glycemic control on metformin

Detailed Description
-----------------
Sitagliptin might improve not only the mean glycemic control during study period but also 24 hour glycemic fluctuation by restoring the physiologic pattern of insulin secretion. Furthermore decrease postprandial glycemic excursion should decrease the oxidative stress markers. Those effects might be amplified in Asian patients because of prominent early phase insulin secretory defects accompanied with relatively less degree of insulin resistance. Based on this assumption, this research will focus on the effect of Sitagliptin on 24 hour glycemic excursion and improvement of oxidative stress markers compared to long acting sulphonylurea Glimepiride in type 2 diabetic patients with inadequate glycemic control on metformin.

Official Title
-----------------
The Comparative Study of Dipeptidyl Peptidase-IV Inhibitor and Sulfonylurea on the Effect of Improving Glucose Variability and Oxidative Stress in Type 2 Diabetic Patients With Inadequate Glycemic Control on Metformin

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Sitagliptin
* Drug: Glimepiride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with type 2 diabetes duration of diabetes less than 10 years HbA1c 6.5-8.0% BMI 20-30 on stable dose of metformin (more than 1000mg) for at least 2 months Exclusion Criteria: having oral hypoglycemic agents other than metformin using insulin serum creatinin >= 1.5 mg/dL SGOT, SGPT >= 90 ischemic heart disease congestive heart failure (NYHA class >=2) severe diabetic complication (PDR, CRF, CVA) on medication affecting glucose profile (such as steroid) infectious disease malignancy pregnant or breast-feeding woman

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Sitagliptin | Drug: Sitagliptin<br>* 100mg P.O. per day for 1month<br>* Other names: Januvia;|
| Active Comparator: 2<br>Glimepiride | Drug: Glimepiride<br>* 2mg P.O. per day for 1 month<br>* Other names: Glimel;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose variability |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidative stress markers (oxidized LDL, N-carboxymethyl-lysine(CML), nitrotyrosine, 8-iso-prostaglandinF2α, 8-OhDG) |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glucose variability, oxidative stress, sitagliptin, glimepiride