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| ID | Type | Description | Link |
|---|---|---|---|
| YY-351-4 |
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The purpose of this trial is to determine the dosage selected and to evaluate the efficacy and safety of YY-351.
Ginseng has been widely studied for treatment of diabetes, dyslipidemia and obesity. Interestingly, in addition to ginseng root, ginseng berry and leaf were also shown to reduce blood glucose in diabetic models. In our recent study, ginsam, vinegar extraction from Panax ginseng, which is enriched in the ginsenoside Rg3, has distinct beneficial effects on glucose metabolism and body weight control in an obese animal model of insulin resistance by changing the expression of genes involved in glucose and fatty acid metabolism. Our group has also published that Rg3 improves insulin signaling and glucose uptake primarily by stimulating the expression of IRS-1 and GLUT4. Thus, we have evaluated the efficacy, dose-response relationships and safety of a ginsam, a vinegar extract from Panax ginseng.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | YY-351, PO, 1T tid. / Placebo, 1T tid. |
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| 2 | Experimental | YY-351. PO, 2T bid. / Placebo 2T qd. |
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| 3 | Experimental | YY-351, PO, 2T tid. |
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| 4 | Placebo Comparator | Placebo, PO, 2T tid. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YY-351/Placebo | Drug | comparison of different dosages of drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the fasting plasma glucose and postprandial glucose [after 2 hours, oral glucose tolerance test (OGTT) (75 g)] and HbA1c | from baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects achieving a glycemic response defined as ≤ 7.0% | from baseline to Week 8 | |
| Decrease of HbA1c > 0.5% | from baseline to Week 8 | |
| Biomarkers [liver function tests (LFT), high-sensitivity C-reactive protein (hsCRP), adiponectin] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soo Lim, MD,PHD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | Bungdang-Gu | 463-707 | 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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| YY-351/Placebo | Drug | comparison of different dosages of drug |
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| YY-351 | Drug | comparison of different dosages of drug |
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| Placebo | Drug | comparison of different dosages of drug |
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| from baseline to Week 8 |
| Body weight (or body composition) | from baseline to Week 8 |
| Waist girth | from baseline to Week 8 |
| Homeostasis model assessment (HOMA) | from baseline to Week 8 |
| Lipid profile | from baseline to Week 8 |