A Randomized, Double Blind Study to Compare the Safety and Tolerability of Aleglitazar and Actos in Patients With Type 2 Diabetes and NYHA Class II Heart Failure.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period.
研究概览
简要总结
This 2 arm study will compare the safety, tolerability and efficacy of aleglitazar and Actos in patients with type 2 diabetes and symptomatic NYHA class II heart failure. Eligible patients will be randomized to receive either aleglitazar, titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily, or Actos, titrated to an individual maximum tolerated dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >=18 years of age;
- •type 2 diabetes for >=1 month;
- •drug naive, or receiving stable doses of <=2 oral antihyperglycemic medications;
- •HbA1c 6.5-10.0% at screening;
- •symptomatic, stable NYHA class 2 heart failure at screening.
排除标准
- •type 1 diabetes;
- •current or previous treatment with insulin;
- •uncontrolled hypertension;
- •NYHA class 1, 3 or 4 at screening.
研究组 & 干预措施
Actos
干预措施: Actos (Drug)
Aleglitazar
干预措施: aleglitazar (Drug)
结局指标
主要结局
Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period.
时间窗: 26 week
次要结局
- Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period, adverse events (AEs), laboratory parameters.(26 week)
- Efficacy: Change from baseline to week 26 in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), fasting plasma insulin (FPI) and lipid profile.(26 week)