A Phase IV, Randomized, Open-label, Parallel-arm, Comparative and Forced- Titration Study to Compare the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Patients With Type 2 DM and Dyslipidemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- The percentage of patients achieving the combined treatment goal of LDL-C < 100mg/dl and non-HDL-C < 130 mg/dl at week 12 with rosuvastatin treatment compared with simvastatin treatment
研究概览
简要总结
This is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with type 2 DM and dyslipidemia. When comparing the efficacy of rosuvastatin 20 mg with simvastatin 40 mg for the treatment of type 2 DM with dyslipidemia, rosuvastatin 20 mg is superior to simvastatin 40 mg in achieving the combined goal of LDL-C (<100 mg/dL) and non-HDL-C (<130 mg/dL).
详细描述
The duration of patient participation will be 18 weeks consisting of a 1-week screening period, a 5-week lead-in period, followed by a 12-week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female between the ages of 20-75 years.
- •Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable method of birth control.
- •Diagnosed with type 2 diabetes mellitus.
- •Fasting triglyceride ≧150 mg/dL ≦500 mg/dL or Non-HDL-C≧130,but≦200 mg/dL
- •Patients receiving stable antidiabetic treatment for 8 weeks before randomization (no change in the category of anti-diabetic agents, but the dose is adjustable).
- •All patients give written informed consent.
排除标准
- •A history of hypersensitivity to statins.
- •A history of rhabdomyolysis or hereditary muscle disorders.
- •Insulin-treated patients.
- •Patient with any conditions of acute or chronic pancreatitis.
- •Creatine kinase ≧3-fold upper limit of normal (ULN).
- •Patients with an estimated creatinine clearance (see note)≦30 ml/min or bilirubin ≧1.5-fold ULN, or chronic active hepatitis or liver function impairment (AST and ALT ≧3-fold ULN).
- •Overt proteinuria (repeat spot urine protein >300mg/dl by dipstick method).
- •Patients are taking cyclosporine.
- •A history of homozygous familial hypercholesterolemia or familial dysbetalipoproteinemia.
- •Patients with alcohol and drug abuse in past 3 years.
- •Serious or unstable medical or psychological conditions.
- •Hypothyroidism (TSH > 5 μIU/mL).
- •In the investigator's opinion, continuation in the study would be detrimental to the patient's well-being or might confound the clinical trial.
研究组 & 干预措施
1
10 mg rosuvastatin for 4 weeks followed by 20 m rosuvastatin for another 8 weeks
干预措施: Rosuvastatin (Drug)
2
20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks
干预措施: Simvastatin (Drug)
结局指标
主要结局
The percentage of patients achieving the combined treatment goal of LDL-C < 100mg/dl and non-HDL-C < 130 mg/dl at week 12 with rosuvastatin treatment compared with simvastatin treatment
时间窗: 12 weeks
次要结局
- Achieving the combined treatment goal of LDL-C (<100 mg/dL) and non-HDL-C (130 mg/dL) at week 4;(4 weeks)
- Percentage of patients achieving the LDL-C goal of <100 mg/dL at week 4 and week 12;(12 weeks)
- Percentage of patients achieving the LDL-C goal of <70 mg/dL at Week;The mean percent change from baseline in lipid profile at week 4 and week 12;(12 weeks)
研究者
vghtpe user
Attending physician
Taipei Veterans General Hospital, Taiwan