NCT01008163

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Yuyu Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	YY-351/Placebo	comparison of different dosages of drug
DRUG	YY-351/Placebo	comparison of different dosages of drug
DRUG	YY-351	comparison of different dosages of drug
DRUG	Placebo	comparison of different dosages of drug

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-11-04
• Last updated: 2019-02-25

Locations

1 site across 1 country: South Korea