Diabetes
Conditions
Keywords
diabetes
Brief summary
The purpose of this trial is to determine the dosage selected and to evaluate the efficacy and safety of YY-351.
Detailed description
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.
Interventions
DRUGYY-351/Placebo
comparison of different dosages of drug
DRUGYY-351
comparison of different dosages of drug
DRUGPlacebo
comparison of different dosages of drug
Sponsors
Yuyu Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previous diagnosis of Type 2 diabetes(more than 3months) * Patients aged over 18 years * FPG levels in the range : 126 - 270mg/dL or HbA1c : 7.0 - 12.0%
Exclusion criteria
* Pregnant women, Breast feeding, or actively trying to be come pregnant * Patients with Type 1 DM, gestational diabetes or secondary diabetes * FPG levels in the range : ≥ 270mg/dL HbA1c : \< 7.0, \>12.0% * Patient who take the medicine which may affect to blood sugar control (i.e.systemic glucocorticoid) * Patients with diabetic complications or the history of a case that would affect to efficacy and safety evaluation (i.e. Thyroid disorder, Cushing's Syndrome, Multiple ovarian cystoma, pheochromocytoma) * Patients with Chronic hepatitis, hepatitis B, C (except healthy HBV carrier) or Liver diseases (AST or/and ALT \>2 × ULN(upper limit normal)) * Patients with Kidney disorder (Cr\>2.0)
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Decrease of HbA1c > 0.5% | from baseline to Week 8 |
| Biomarkers [liver function tests (LFT), high-sensitivity C-reactive protein (hsCRP), adiponectin] | from baseline to Week 8 |
| Body weight (or body composition) | from baseline to Week 8 |
| Subjects achieving a glycemic response defined as ≤ 7.0% | from baseline to Week 8 |
| Homeostasis model assessment (HOMA) | from baseline to Week 8 |
| Lipid profile | from baseline to Week 8 |
| Waist girth | from baseline to Week 8 |
Countries
South Korea
Outcome results
None listed