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The study design of this trial is double blind, parallel-group, randomized, placebo controlled study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator |
| |
| MP-513 group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP-513 | Drug | form : Pink film-coated tablet for oral administration Dosage : 20mg/tablet frequency and duration: 1 tablet/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated hemoglobin | Visit 1(Baseline Visit) vs Visit 7(week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean fasting plasma glucose | Visit 1(Baseline Visit) vs Visit 7(week 24) | |
| Weight | Visit 1(Baseline Visit) vs Visit 7(week 24) | |
| Glycosylated hemoglobin <7.0% subject percent |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sungwoo Park | Kangbuk Samsung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Handok INC | Seoul | Gangnam-Gu | South Korea | |||
| Handok Pharmaceuticals CO. LTD |
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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 | Pink film-coated tablet for oral administration, frequency and duration: 1 tablet/day |
|
| Visit 1(Baseline Visit) vs Visit 7(week 24) |
| Triglycerides | Visit 1(Baseline Visit) vs Visit 7(week 24) |
| Homeostatic model assessment of insulin Resistance | Visit 1(Baseline Visit) vs Visit 7(week 24) |
| Body mass index | Visit 1(Baseline Visit) vs Visit 7(week 24) |
| Low Density Lipoprotein | Visit 1(Baseline Visit) vs Visit 7(week 24) |
| High Density Lipoprotein | Visit 1(Baseline Visit) vs Visit 7(week 24) |
| Cholesterol | Visit 1(Baseline Visit) vs Visit 7(week 24) |
| Connecting peptide | Visit 1(Baseline Visit) vs Visit 7(week 24) |
| Insulin | Visit 1(Baseline Visit) vs Visit 7(week 24) |
| Homeostatic model assessment of beta-cell function | Visit 1(Baseline Visit) vs Visit 7(week 24) |
| Glycosylated hemoglobin <6.5% subject percent | Visit 1(Baseline Visit) vs Visit 7(week 24) |
| Seoul |
| South Korea |
| D004700 | Endocrine System Diseases |