A Multi-center, Randomized, Double-blind, Active-controlled, Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
A Multi-center, Randomized, double-blind, active-controlled, phase 3 trial to evaluate the safety and efficacy of Metformin/Atorvastatin in subjects with Type II Diabetes and dyslipidemia.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Dyslipidemia and Type II Diabetes
- •19 years later, men and women under the age of 80
排除标准
- •Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
- •Subject with type I Diabetes
- •Subject with hypertension which does not controlled by treatment(have blood pressure > 180/110mmHg)
研究组 & 干预措施
Metformin/Atorvastatin
Metformin/Atorvastatin, QD
干预措施: Metformin/Atorvastatin 1500mg/40mg, QD (Drug)
Metformin
Metformin, QD
干预措施: Atorvastatin 40mg, QD (Drug)
Atorvastatin
Atorvastatin, QD
干预措施: Metformin 1500mg, QD (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Change from baseline at 16 weeks
Change in HbA1c after 16 weeks, relative to baseline, between the combination of Metformin 1500 mg and Atorvastatin 40 mg compared to Atorvastatin 40 mg alone
Change in LDL Cholesterol
时间窗: Change from baseline at 16 weeks
Change in low-density lipoprotein cholesterol (LDL-C) after 16 weeks, relative to baseline, between Metformin 1500 mg alone and the combination of Metformin 1500 mg and Atorvastatin 40 mg
次要结局
- Change in LDL-C(Baseline and 16 weeks)
- Change in HbA1c(Baseline and 16 weeks)
- Percentage of subjects reaching the LDL-C treatment goal defined by the NCEP ATP III guideline (<100mg/dL) after 16 weeks of treatment with investigational products(16 weeks)
- Percentage of subjects reaching HbA1c <7.0% and <6.5% after 16 weeks of treatment with investigational products(16 weeks)
- Change in LDL-C and the associated rate of change after 4, 8, and 12 weeks of treatment with investigational products compared to baseline(Baseline, 4 weeks, 8 weeks and 12 weeks)
- Change in LDL-C after 16 weeks, relative to baseline, in subjects treated with investigational products(Baseline and 16 weeks)
- Change in lipid variables and the associated rate of change(Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks)
- Change in average fasting plasma glucose (FPG) after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline(Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks)
- Change in Insulin, HOMA-β, HOMA-IR after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline.(Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks)