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Objective of the trial is to assess dose-dependency, efficacy and safety and to estimate optimum dosage for confirmatory study of CWP-0403 50mg, 100mg given twice daily for 12 weeks to type 2 diabetes patients who are insufficiently controlled by diet and exercise in comparison to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CWP-0403 50mg | Experimental |
| |
| CWP-0403 100mg | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CWP-0403 100mg | Drug | 100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c before and after treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c target achievement rate(Ratio of the patients with HbA1c lower than 6.5% or 7%) | 12 weeks | |
| Fasting blood glucose level change and rate of change | 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KunHo Yoon | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Seoul | South Korea | ||||
| Ewha Womans University Mokdong 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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| placebo |
| Drug |
Tablet not containing CWP-0403 and indistinguishable from CWP-0403 50mg, 100mg tablets. Twice a day, 1 tablet at a time for 12 weeks |
|
| CWP-0403 50mg | Drug | 50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks |
|
| Serum insulin, serum C-peptide level change |
| 12 weeks |
| HOMA-R and HOMA-β change rate | 12 weeks |
| Triglyceride, LDL-cholesterol and HDL-cholesterol change | 12 weeks |
| Seoul |
| South Korea |
| Gachon Medical School Gil Medical Center | Seoul | South Korea |
| Inha University Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Kyungpook National University Hospital | Seoul | South Korea |
| Seoul National University Bundang Hopital | Seoul | South Korea |
| The Catholic University of Korea, Holly Family Hospital | Seoul | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | South Korea |
| The Catholic University of Korea, St. Vincent's Hospital | Seoul | South Korea |
| D004700 | Endocrine System Diseases |