NCT00044460已完成4 期
A 24-week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients With Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 142
- 主要终点
- Change in HbA1c from baseline to Week 24.
研究概览
简要总结
The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Drug-naive.
- •Laboratory test result for HbA1c of greater than or equal to 10%.
- •Written informed consent.
排除标准
- •Prior use of antidiabetic medications within 3 months of screening.
- •Fluid retention (edema).
- •Significant liver disease.
- •Low red blood cells (anemia).
- •Severe or unstable angina (chest pain).
- •Congestive heart failure.
- •Severe high blood pressure.
- •Alcohol or drug abuse.
- •Other inclusion or exclusion criteria to be determined by the physician and study sponsor.
结局指标
主要结局
Change in HbA1c from baseline to Week 24.
次要结局
- Change in FPG (fasting plasma glucose) from baseline to Week 24; characterize the effects of rosiglitazone on the albumin-creatinine ratio at Week 24.
研究者
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