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The purpose of this study is to assess the safety and effectiveness of three doses of CKD-501 compared to placebo in lowering fasting plasma glucose levels in people with type 2 diabetes for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-501 0.5mg | Experimental |
| |
| CKD-501 1mg | Experimental |
| |
| CKD-501 2mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-501 0.5mg | Drug | 0.5 mg/tablet, orally, 1 tablet once daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in fasting plasma glucose at 8 weeks | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Glycemic parameters after 8 weeks | 8 weeks | |
| Change from baseline in Lipid parameters after 8 weeks | 8 weeks | |
| Adverse event profile after 8 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dongseop Choi, MD.,Ph.D. | The Korea University Anam Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Inje University Medical Center | Busan | South Korea | ||||
| The Yeungnam University Hospital |
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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 |
|---|---|
| C546215 | lobeglitazone |
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| CKD-501 1mg | Drug | 1 mg/tablet, orally, 1 tablet once daily for 8 weeks |
|
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| CKD-501 2mg | Drug | 2 mg/tablet, orally, 1 tablet once daily for 8 weeks |
|
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| Placebo | Drug | orally, 1 tablet once daily for 8 weeks |
|
| 8 weeks |
| Daegu |
| South Korea |
| The Chtholic University of Korea Uijeongbu St. Mary's Hospital | Gyeonggi-do | South Korea |
| The Seoul National Univertisy Bundang Hospital | Gyeonggi-do | South Korea |
| The Wonju Christian Hospital | Kangwon-Do | South Korea |
| The Inje University Sanggye-Paik Hospital | Seoul | South Korea |
| The Korea University Anam Hospital | Seoul | South Korea |
| The Samsung Medical Center | Seoul | South Korea |
| D004700 | Endocrine System Diseases |