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

Phase 2

Completed

• Conditions: Diabetes
• Interventions: Drug: YY-351/Placebo; Drug: Placebo; Drug: YY-351

• Registration Number: NCT01008163
• Lead Sponsor: Yuyu Pharma, Inc.

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-10-20
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	YY-351/Placebo	YY-351, PO, 1T tid. / Placebo, 1T tid.
4	Placebo	Placebo, PO, 2T tid.
2	YY-351/Placebo	YY-351. PO, 2T bid. / Placebo 2T qd.
3	YY-351	YY-351, PO, 2T tid.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Bungdang-Gu, Korea, Republic of