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

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

Detailed Description
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Drug: YY-351/Placebo
* Drug: YY-351/Placebo
* Drug: YY-351
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>YY-351, PO, 1T tid. / Placebo, 1T tid. | Drug: YY-351/Placebo<br>* comparison of different dosages of drug<br>* Other names: Ginsam;|
| Experimental: 2<br>YY-351. PO, 2T bid. / Placebo 2T qd. | Drug: YY-351/Placebo<br>* comparison of different dosages of drug<br>* Other names: Ginsam;|
| Experimental: 3<br>YY-351, PO, 2T tid. | Drug: YY-351<br>* comparison of different dosages of drug<br>* Other names: Ginsam;|
| Placebo Comparator: 4<br>Placebo, PO, 2T tid. | Drug: Placebo<br>* comparison of different dosages of drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Body weight (or body composition) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes