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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008163
• Other study ID #: YY351-1
• Secondary ID: YY-351-4
• Status: Completed
• Phase: Phase 2
• Start date: January 2008
• Est. completion date: June 2009

Study information

• Verified date: February 2019
• Source: Yuyu Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Drug:
• YY-351/Placebo
comparison of different dosages of drug
• YY-351/Placebo
comparison of different dosages of drug
• YY-351
comparison of different dosages of drug
• Placebo
comparison of different dosages of drug

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Bungdang-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Yuyu Pharma, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Subjects achieving a glycemic response defined as = 7.0%		from baseline to Week 8
Secondary	Decrease of HbA1c > 0.5%		from baseline to Week 8
Secondary	Biomarkers [liver function tests (LFT), high-sensitivity C-reactive protein (hsCRP), adiponectin]		from baseline to Week 8
Secondary	Body weight (or body composition)		from baseline to Week 8
Secondary	Waist girth		from baseline to Week 8
Secondary	Homeostasis model assessment (HOMA)		from baseline to Week 8
Secondary	Lipid profile		from baseline to Week 8