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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glimepiride | Experimental | Starting with Glimepiride. After 3 month, switching to vildagliptin. |
|
| Vildagliptin | Experimental | Starting with vildagliptin. After 3 month, switching to Glimepiride. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glimepiride | Drug |
| ||
| Vildagliptin |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hye Seung Jung, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C057619 | glimepiride |
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |