A Phase Ⅱ, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Efficacy and Safety of YY-351 in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change from baseline in the fasting plasma glucose and postprandial glucose [after 2 hours, oral glucose tolerance test (OGTT) (75 g)] and HbA1c
研究概览
简要总结
The purpose of this trial is to determine the dosage selected and to evaluate the efficacy and safety of YY-351.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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)
研究组 & 干预措施
2
YY-351. PO, 2T bid. / Placebo 2T qd.
干预措施: YY-351/Placebo (Drug)
1
YY-351, PO, 1T tid. / Placebo, 1T tid.
干预措施: YY-351/Placebo (Drug)
3
YY-351, PO, 2T tid.
干预措施: YY-351 (Drug)
4
Placebo, PO, 2T tid.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the fasting plasma glucose and postprandial glucose [after 2 hours, oral glucose tolerance test (OGTT) (75 g)] and HbA1c
时间窗: from baseline to Week 8
次要结局
- 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)