NCT01544309已完成不适用
Study on Effect of Highly Potent Statins on Lipid Lowering Effect and Glucose Metabolism in Hypercholesterolemia Patients With Diabetes Mellitus
Listen Trial Group133 个研究点 分布在 1 个国家目标入组 1,049 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,049
- 试验地点
- 133
- 主要终点
- Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level
研究概览
简要总结
The purpose of this study is to compare the effect of rosuvastatin and atorvastatin on lipid lowering effect and glucose metabolism in hypercholesterolemia patients with diabetes mellitus.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypercholesterolemia patients
- •Patients who have not achieved the target control levels of LDL-C in the "Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007"
- •Type 2 diabetes patients
- •Patients diagnosed with type 2 diabetes and receiving diet therapy, exercise therapy, or medication
- •Patients who received constant therapy for three months before registration and have no plan for therapy change
- •Patients with kept HbA1c level (Japan Diabetes Society [JDS] level) of less than 7.0% (or, National Glycohemoglobin Standardization Program [NGSP] level of less than 7.4%) within three months before registration
- •Patients receiving or not receiving medication at present
- •Patients giving voluntary written consent to participate in the study
- •Male or female patients at 20 years or older
排除标准
- •Patients who administered rosuvastatin, atorvastatin or ezetimibe within three month at the registration
- •Patients with severe hypertension (systolic blood pressure [SBP] ≥ 180 mmHg or diastolic blood pressure [DBP] ≥ 110 mmHg)
- •Patients with type 1 diabetes
- •Patients judged to have familial hypercholesterolemia
- •Patients with a serum triglyceride level of ≥ 400 mg/dL
- •Patients who had the onset of cardiovascular or cerebrovascular disease within three months
- •Patients with serious heart failure (NYHA classification III - IV)
- •Patients with a history of hypersensitivity to statins
- •Patients with a history of drug-induced myopathy
- •Patients with severe complication of diabetes
- •Patients receiving insulin
- •Patients with serious liver or kidney disease
- •Patients with serious concurrent disease such as malignancy, or patients with severely limited lifespan
- •Patients who are or may be pregnant
- •Patients judged by the investigators to be ineligible for participation in the study for any other reason
研究组 & 干预措施
Atorvastatin administration group
Experimental
干预措施: Atorvastatin (Drug)
Rosuvastatin administration group
Experimental
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level
时间窗: Baseline, and 12 months after administration
Change in HbA1c Level
时间窗: Baseline, 12 months after administration
次要结局
- Change in HbA1c Level(Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）)
- Percent Change in Insulin Level(Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）)
- Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status(Baseline, 3, 6, 12 months after administration)
- Percent Change in 1,5-AG Level(Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）)
- Percent Change in Non-HDL-C Level(Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment)
- Occurrence of Deterioration of Diabetic Treatment Status(Baseline, 12 months after administration)
- Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA)(Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment)
- Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease)(From the start of the treatment to the end of study treatment)
- Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation(Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment)
- Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007(3 months after administration, the end of starting dose and the end of study treatment)
- Change in Blood Glucose Level (Fasting)(Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）)
- Change From Baseline in Insulin Level(Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）)
- Change From Baseline in 1,5-AG Level(Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）)
- Percent Change in Blood Glucose Level (Fasting)(Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）)
- Frequency of Serious Adverse Events (SAE)(Up to 12 months)
研究者
研究点 (133)
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