A Randomized Double Blind, Placebo-controlled Clinical Trial to Assess the Effects of Taspoglutide (RO5073031) on Cardiovascular Outcomes in Subjects With Inadequately Controlled Type 2 Diabetes and Established Cardiovascular Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,118
- 主要终点
- Time to cardiovascular composite primary endpoints
研究概览
简要总结
This randomized, double-blind, placebo-controlled parallel arm study will assess efficacy and safety and the effects of taspoglutide on cardiovascular events in patients with inadequately controlled type 2 diabetes mellitus and established cardiovascular disease. Patients will be randomized to receive either taspoglutide subcutaneously (sc) 10mg weekly for 4 weeks followed by 20mg sc weekly, or weekly sc placebo, in addition to background anti-hyperglycemic medication and standard of care treatment for cardiovascular disease. Anticipated time on study treatment is up to 2 years. Target sample size is 2000 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
- •HbA1c >/=6.5% and </=10% at screening
- •BMI >/=23kg/m2
- •cardiovascular disease with onset >/=1 month prior to screening
排除标准
- •diagnosis or history of type 1 diabetes or secondary forms of diabetes
- •acute metabolic diabetic complications within past 6 months
- •severe hypoglycemia </=1 month prior to screening
- •clinically significant gastrointestinal disease
- •history of chronic or acute pancreatitis
- •current New York Heart Association (NYHA) class IV heart failure or post-transplantation cardiomyopathy
- •severely impaired renal function
研究组 & 干预措施
placebo
干预措施: placebo (Drug)
taspoglutide
干预措施: taspoglutide (Drug)
结局指标
主要结局
Time to cardiovascular composite primary endpoints
时间窗: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
次要结局
- Secondary cardiovascular composite endpoints(event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter)
- Individual components of primary cardiovascular composite endpoints(event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter)
- Total mortality(assessed at end of study, week 104)
- Metabolic and renal function parameters: HbA1c, fasting plasma glucose, body weight, lipid profile, albumin/creatinine ratio (ACR), albuminuria, glomerular filtration rate (GFR)(laboratory assessments weeks 4 and 12, and every 3 to 6 months thereafter)