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

NCT ID: NCT01008163

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-06-30

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

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

Group Type: EXPERIMENTAL

YY-351/Placebo

Intervention Type: DRUG

comparison of different dosages of drug

2

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

Group Type: EXPERIMENTAL

YY-351/Placebo

Intervention Type: DRUG

comparison of different dosages of drug

3

YY-351, PO, 2T tid.

Group Type: EXPERIMENTAL

YY-351

Intervention Type: DRUG

comparison of different dosages of drug

4

Placebo, PO, 2T tid.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

comparison of different dosages of drug

Interventions

YY-351/Placebo

comparison of different dosages of drug

Intervention Type: DRUG

YY-351/Placebo

comparison of different dosages of drug

Intervention Type: DRUG

YY-351

comparison of different dosages of drug

Intervention Type: DRUG

Placebo

comparison of different dosages of drug

Intervention Type: DRUG

Other Intervention Names

Ginsam; Ginsam; Ginsam

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuyu Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soo Lim, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam, Bungdang-Gu, South Korea

Countries

South Korea

Other Identifiers

YY-351-4

Identifier Type: -

Identifier Source: secondary_id

YY351-1

Identifier Type: -

Identifier Source: org_study_id