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We will evaluate the efficacy and safety of combination therapy of 10 mg mitiglinide or 0.2mg voglibose with insulin glargine for 16 weeks after single administration of insulin glargine for 4 weeks in type 2 diabetic patients whose glycemic control were not enough despite administration of oral antidiabetic drug or insulin glargine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M | Experimental | Mitiglinide |
|
| V | Active Comparator | Voglibose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitiglinide | Drug | mitiglinide 10mg three times a day before a meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of HbA1c before and after administration of test drug | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of self-monitoring of blood glucose before and after administration of test drug | 20 weeks | |
| Change of insulin dose before and after administration of test drug | 20 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kun-ho Yoon | The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital | Seoul | 137-701 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26411328 | Derived | Son JW, Lee IK, Woo JT, Baik SH, Jang HC, Lee KW, Cha BS, Sung YA, Park TS, Yoo SJ, Yoon KH. A prospective, randomized, multicenter trial comparing the efficacy and safety of the concurrent use of long-acting insulin with mitiglinide or voglibose in patients with type 2 diabetes. Endocr J. 2015;62(12):1049-57. doi: 10.1507/endocrj.EJ15-0325. Epub 2015 Sep 25. |
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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 |
|---|---|
| C087255 | mitiglinide |
| C102817 | voglibose |
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| Voglibose | Drug | voglibose 0.2mg three times a day before a meal |
|
|
| Achievement rate of HbA1c target level (rate of the patients whose HbA1c were improved under 6.5% after administration) |
| 20 weeks |
| Change of CRP, 8-OHdG and Nitrotyrosine before and after administration of test drug | 20 weeks |
| D004700 | Endocrine System Diseases |