NCT02827903已完成3 期
A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 33
- 主要终点
- change of HbA1c
研究概览
简要总结
Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia
详细描述
Multi-center, Randomized, Double-blind, Phase III clinical trial
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 19 years
- •Type II DM with Dyslipidemia
- •6.5% ≤ HbA1c < 11%
- •Triglyceride < 350mg/dL
- •100mg/dL ≤ LDL-C ≤ 250mg/dL
- •FPG ≤ 270mg/dL
排除标准
- •Type I DM
- •Unstable angina, MI, Stroke, CABG with 6 month from screening
- •SBP ≥ 180mmHg, DBP ≥ 110mmHg
- •TSH > UNL
- •Heart failure (NYHA class III/IV)
- •Serum Creatinine > UNL or CLCr < 60 mL/min
- •CK ≥ 2x UNL
- •HIV positive
- •BMI > 40 kg/m^2
研究组 & 干预措施
Group I
Experimental
Metformin + Rosuvastatin, Dosing to Type II DM with Dyslipidemia
干预措施: Metformin + Rosuvastatin (Drug)
Group II
Active Comparator
Metformin + placebo, Dosing to Type II DM with Dyslipidemia
干预措施: Metformin + placebo (Drug)
Group III
Active Comparator
Placebo + Rosuvastatin, Dosing to Type II DM with Dyslipidemia
干预措施: placebo + Rosuvastatin (Drug)
结局指标
主要结局
change of HbA1c
时间窗: 16 weeks from baseline
LDL-C (% change)
时间窗: 16 weeks from baseline
次要结局
未报告次要终点
研究者
研究点 (33)
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