NCT02035644Unknown4 期
Study on the Efficacy aNd Safety of Jinlida Granules in Patients With Inadequately cOntrolled tYpe-2 Diabetes and dysLIpidemia Under liFe Style Intervention (ENJOY LIFE Study)
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- change in HbA1c levels
研究概览
简要总结
The aim of the present study is to evaluate the efficacy and safety of Jinlida granules in patients with inadequately controlled type-2 diabetes and dyslipidemia under life style intervention.
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
- Double
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age of 20-70 years;
- •diagnosed with type 2 diabetes inadequately controlled under life style intervention with 3 months before screening;
- •HbA1c ≥6.5% and ≤10.0%, and fasting plasma glucose ≥7 and ≤13.3mmol/L at baseline;
- •diagnosed with dislipidemia with triglycerides>150mg/dL (1.70mmol/L), and/or total cholesterol >200mg/dL (5.16mmol/L), and/or LDL-c>100mg/dL (2.58mmol/L)
- •body mass index (BMI): 20<BMI<40 kg/m2;
排除标准
- •moderate or severe liver dysfunction, abnormal renal function;
- •severe dysfunction of the heart;
- •histories of acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma within 3 months;
- •psychiatric disease or severe infection;
- •pregnancy or planned pregnancy;
- •use of any drug (including insulin) for treatment of diabetes or dyslipidemia within 3 months;
- •use of chronic (>7 days) systemic glucocorticoid therapy within 8 weeks or receive growth hormone therapy within 6 months;
- •diagnosed with type 1 diabetes, or gestational diabetes, or other specific types of diabetes;
- •history of malignant tumor within 5 years.
研究组 & 干预措施
Jinlida granules
Experimental
Jinlida granules, a traditional Chinese medicine, was a herbal formula which was developed under cognition of the theory in the onset of diabetes
干预措施: Jinlida granules (Drug)
placebo granules
Placebo Comparator
placebo prepared in indistinguishable granules
干预措施: placebo granules (Drug)
结局指标
主要结局
change in HbA1c levels
时间窗: 16 weeks
次要结局
- blood pressures(16 weeks)
- BMI(16 weeks)
- fasting, postload 30-min and 2-h plasma glucose(16 weeks)
- fasting, postload 30-min and 2-h serum insulin(16 weeks)
- serum lipids(16 weeks)
- glucose disposal rate (GDR) values from hyperinsulinemic euglycemic clamp(16 weeks)
- incretins(16 weeks)
- metabolomic parameters(16 weeks)
研究者
Guang Ning
the vice-president of Shanghai Jiao Tong University Affiliated Ruijin Hospital
Shanghai Jiao Tong University School of Medicine
研究点 (1)
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