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The purpose of this study is to compare the effect of vildagliptin vs. pioglitazone to oxidative stress on daily blood glucose fluctuations, in patients with type 2 diabetes that was inadequately controlled by metformin.
Activation of oxidative stress by glucose fluctuations plays a major role in the pathogenesis of diabetic complication. Dipeptidyl peptidase IV (DPP-IV), such as vildagliptin, enhances glucose-induced insulin secretion, decreases glucagon secretion, and reduces postprandial hyperglycemia and may also improve acute fluctuations of glucose. We believe that vildagliptin may exert an effect of decreasing oxidative stress by reducing glucose excursion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone | Active Comparator | pioglitazone: 15mg, QD, PO, 16 weeks |
|
| vildagliptin | Experimental | vildagliptin 50mg,BID,PO,16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galvus (vildagliptin) | Drug | 50mg BID, PO, for 16 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Variability | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Oxidative stress | 16 weeks | |
| HbA1C | 16 weeks | |
| hypoglycemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sin-Gon Kim, Dr., Ph.D. | Contact | 82-2-920-5830 | k50367@korea.ac.kr | |
| Juri Park, Dr.,Ph.D | Contact | 82-2-2224-2590 | poirio@naver.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| pioglitazone |
| Drug |
15mg, QD, PO, 16 weeks |
|
| 16 weeks |
| D006571 |
| Heterocyclic Compounds |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |