NCT01043029已完成2 期
Effects of 150 mcg Aleglitazar on Renal Function in Patients With Type 2 Diabetes and Moderate Renal Impairment, as Compared to Actos®
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
- 302
- 主要终点
- Renal function: estimated glomerular filtration rate
研究概览
简要总结
This multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses. In addition, a diet and exercise plan will also be implemented during the anticipated time on study treatment of 52 weeks. The target sample size is 200-400 patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients >/= 18 years of age
- •Diabetes mellitus, Type 2
- •Moderately impaired kidney function
- •Drug naive or up to 2 antihyperglycemic medications at stable dose for over 1 month at screening
- •BMI 25-35
排除标准
- •Current or previous treatment with a thiazolidinedione
- •Current or previous treatment with insulin
- •Treatment with fibrates <3 months prior to screening
- •History of renal disease other than diabetic nephropathy
研究组 & 干预措施
aleglitazar
Experimental
干预措施: aleglitazar (Drug)
pioglitazone
Active Comparator
干预措施: pioglitazone (Drug)
结局指标
主要结局
Renal function: estimated glomerular filtration rate
时间窗: Week 60
次要结局
- Renal function: estimated glomerular filtration rate(Week 52)
- Effect on blood hemoglobin(Week 52)
- Safety, Tolerability: Adverse events (AEs), laboratory parameters(AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60)
研究者
相似试验
已完成
不适用
Effects of 150 mcg Aleglitazar on Renal Function in Patients With Type 2 Diabetes and Moderate Renal Impairment, as Compared to Actos®-E11 Non-insulin-dependent diabetes mellitusNon-insulin-dependent diabetes mellitusE11PER-022-10F. HOFFMANN-LA ROCHE LTD.,7
进行中（未招募）
不适用
Effects of 150 µg aleglitazar on renal function in patients with Type 2 diabetes and moderate renal impairment, as compared to Actos. - NDEUCTR2009-012270-12-ITF. Hoffmann - La Roche Ltd.300
进行中（未招募）
不适用
Effects of 150 µg aleglitazar on renal function in patients with Type 2 diabetes and moderate renal impairment, as compared to Actos®Type 2 diabetes with moderate renal function impairmentMedDRA version: 12.0Level: LLTClassification code 10007649Term: Cardiovascular disorderEUCTR2009-012270-12-HUF. Hoffmann-La Roche Ltd.300
进行中（未招募）
不适用
Effects of 150 µg aleglitazar on renal function in patients with Type 2 diabetes and moderate renal impairment, as compared to Actos®Type 2 diabetes with moderate renal function impairmentMedDRA version: 12.0Level: LLTClassification code 10007649Term: Cardiovascular disorderEUCTR2009-012270-12-DEF. Hoffmann-La Roche Ltd.300
进行中（未招募）
不适用
Effects of 150 µg aleglitazar on renal function in patients with Type 2 diabetes and moderate renal impairment, as compared to Actos®Type 2 diabetes with moderate renal function impairmentMedDRA version: 12.0Level: LLTClassification code 10007649Term: Cardiovascular disorderEUCTR2009-012270-12-SKF. Hoffmann-La Roche Ltd.300