NCT00461006已完成2 期
A Randomized, Double Blind Study to Compare the Effects of Aleglitazar and Actos on Glomerular Filtration Rate and Other Parameters of Renal Function in Patients With Type 2 Diabetes.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 176
- 主要终点
- Relative change from baseline in glomerular filtration rate
研究概览
简要总结
This 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function. Eligible patients will be randomized to receive either aleglitazar 0.6mg p.o. or Actos 45mg p.o. daily. Renal function and efficacy parameters will be assessed at intervals during the treatment period. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-75 years of age;
- •type 2 diabetes for >=1 month;
- •drug naive, or receiving stable oral antihyperglycemic medication;
- •HbA1c 6.5-10.0% at screening.
排除标准
- •type 1 diabetes;
- •current or previous treatment with insulin;
- •history of renal disease other than diabetic nephropathy;
- •uncontrolled hypertension;
- •clinically significant cardiovascular disease;
- •Congestive heart failure (CHF) New York Heart Association (NYHA) 3-4.
研究组 & 干预措施
Actos
Active Comparator
干预措施: Actos (Drug)
Aleglitazar
Experimental
干预措施: aleglitazar (Drug)
结局指标
主要结局
Relative change from baseline in glomerular filtration rate
时间窗: 26 weeks
次要结局
- Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR)(26 weeks)
- Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI).(End of treatment)
- Adverse events (AEs), laboratory parameters.(Throughout study)
研究者
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