Effects of Vildagliptine and Glimepiride on Glucose Variability

Study Overview
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Brief Summary
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The purpose of this study is to analyze the differences of blood sugar level and glycemic variability between sulfonylurea and DPP-4 inhibitor groups applying CGMS for a chosen number of type 2 DM patients. The investigators also reveal influences of each drugs on cardiovascular risk factors by measuring related biomarkers.

Detailed Description
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We enroll patients with type 2 DM with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%). Before drug administration, we conduct basal lab study including CGMS. After 3 month of random administration of vildagliptin or glimepiride, we check CGMS, glucose levels, CV biomarkers, and estimate hypoglycemic index. We replace with the other drug for 3 months, and then conduct the same measurements. No wash-out period is necessary since result variables are measured after the 3 months of administration for a different drug.

Official Title
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Effects of Vildagliptine and Glimepiride on Glycemic Variability and Cardiovascular Parameters in Patients With Type 2 Diabetes by CGMS

Conditions
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Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
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* Drug: Glimepiride
* Drug: Vildagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: with type 2 DM with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%). Provided that the tolerance for metformin is poor, enrollment of patients with lower dose of metfomrin is open. who have never been prescribed with test drugs, sulfonylurea or DPP-4 inhibitor/GLP-1 analogue in 3 months who can be applied with CGMS Exclusion Criteria: who has liver function abnormality or renal function abnormality who has any kind of diseases, operations, medical treatments that can affect glucose levels

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glimepiride<br>Starting with Glimepiride. After 3 month, switching to vildagliptin. | Drug: Glimepiride<br> <br> Drug: Vildagliptin<br> <br> |
| Experimental: Vildagliptin<br>Starting with vildagliptin. After 3 month, switching to Glimepiride. | Drug: Glimepiride<br> <br> Drug: Vildagliptin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic variability index |  | before and after 3 months of each drug administration | 
| Cardiovascular disease risk factor |  | before and after 3 months of each drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose profile and lipid profile |  | before and after 3 months of each drug administration | 
| hypoglycemic index |  | before and after 3 months of each drug administration |