Trial | NCT01008163  Report issue

Title

A Dose-Finding, Efficacy and Safety Study of YY-351 in Patients With Type 2 Diabetes
A Phase Ⅱ, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Efficacy and Safety of YY-351 in Patients With Type 2 Diabetes Mellitus

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    yy-351 ...

  • Study Participants

    72
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.
Study Started
Jan 31
2008
Primary Completion
Jun 30
2009
Study Completion
Jun 30
2009
Last Update
Feb 25
2019

Drug YY-351/Placebo

comparison of different dosages of drug

  • Other names: Ginsam

Drug YY-351/Placebo

comparison of different dosages of drug

  • Other names: Ginsam

Drug YY-351

comparison of different dosages of drug

  • Other names: Ginsam

Drug Placebo

comparison of different dosages of drug

1 Experimental

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

2 Experimental

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

3 Experimental

YY-351, PO, 2T tid.

4 Placebo Comparator

Placebo, PO, 2T tid.

Criteria 

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)
No Results Posted