12-week, Open-label, Multi-center, Prospective Study Evaluating the Effect of Individualizing Starting Doses of Rosuvastatin According to Baseline LDL (Low Density Lipoprotein)-Cholesterol Levels on Achieving Cholesterol Targets in Type 2 Diabetic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 598
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Achieving Canadian Low Density Lipoprotein Cholesterol (LDL-C) Target Goals (i.e. LDL-C ≤ 2.0 mmol/L) After 12 Weeks of Rosuvastatin Therapy
研究概览
简要总结
This study will assess if customizing the start dose of rosuvastatin appropriate for the degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with either no titration or just one titration step after 6 weeks of therapy in type 2 diabetic patients previously treated with another statin and not at LDL-C targets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of Type 2 diabetes
- •Previously treated with a commonly accepted start dose of a statin for the last 4 weeks prior to study entry
- •Fasting LDL-C concentration of > 2.0 mmol/L (and ≤ 5.0 mmol/L) (in the past 3 months)
- •History of serum TG level of ≤ 4.6 mmol/l (in the past 3 months)
排除标准
- •If currently receiving therapy with any statin at a dose higher than listed
- •Rosuvastatin (current use)
- •Fibrates, niacin or resins that was not discontinued a minimum of 2 months prior to enrolment.
- •Type 1 diabetes; glycated haemoglobin (HbA1c) > 9.0%
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 1.5 × upper limit of normal (ULN) (in the past 2 months)
- •Resting diastolic or systolic blood pressure of > 95 mmHg or > 180 mmHg, respectively (in the past 2 months)
- •Unexplained serum creatine kinase (CK) level > 3 × ULN (in the past 2 months).
研究组 & 干预措施
Rosuvastatin 1
titrated
干预措施: Rosuvastatin (Drug)
Rosuvastatin 2
Non-titrated
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Percentage of Subjects Achieving Canadian Low Density Lipoprotein Cholesterol (LDL-C) Target Goals (i.e. LDL-C ≤ 2.0 mmol/L) After 12 Weeks of Rosuvastatin Therapy
时间窗: 12 Weeks
The number of subjects achieving Canadian Low density lipoprotein cholesterol (LDL-C) target goals (i.e. LDL-C ≤ 2.0 mmol/L) over the total number subjects treated after 12 weeks of rosuvastatin therapy multiplied by 100
次要结局
- Percentage of Subjects Achieving Total Cholesterol (TC)/ High-density Lipoprotein Cholesterol (HDLC) Ratio (i.e. TC/HDL < 4.0 mmol/L) at 6 and 12 Weeks of Treatment(6 and 12 Weeks)
- Mean Percent Change in Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDLC) , TC/HDL-C Ratio, Non-HDL-C, Triglycerides and Apolipoprotein B (ApoB) /Apolipoprotein A1 (ApoA-1) Ratio(6 and 12 Weeks)
- Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12(6 and 12 Weeks)
- Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy(6 and 12 Weeks)