A Dose-Finding, Efficacy and Safety Study of YY-351 in Patients With Type 2 Diabetes

Yuyu Pharma

Status and phase: Completed; Phase 2

Conditions: Diabetes

Treatments: Drug: YY-351/Placebo; Drug: Placebo; Drug: YY-351

Study type: Interventional

Funder types: Industry

Identifiers

NCT01008163

YY351-1

YY-351-4

Details and patient eligibility

About

The purpose of this trial is to determine the dosage selected and to evaluate the efficacy and safety of YY-351.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

YY-351, PO, 1T tid. / Placebo, 1T tid.

Treatment:

Drug: YY-351/Placebo

Drug: YY-351/Placebo

2

Experimental group

Description:

YY-351. PO, 2T bid. / Placebo 2T qd.

Treatment:

Drug: YY-351/Placebo

Drug: YY-351/Placebo

3

Experimental group

Description:

YY-351, PO, 2T tid.

Treatment:

Drug: YY-351

4

Placebo Comparator group

Description:

Placebo, PO, 2T tid.

Treatment:

Drug: Placebo