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
- 发起方
- 入组人数
- 2,000
- 试验地点
- 25
- 主要终点
- Time to first occurrence of any component of a cardiovascular composite endpoint (CV death, MI, stroke, resuscitated cardiac arrest, hospitalization for unstable angina or hospitalization for heart failure)
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 globally and 350 patients from India. The anticipated date of enrollment for the Indian arm is April 15, 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria: adult patients, more than 18 years of age diabetes mellitus type 2 HbA1c more than or equal to 6.5% and less than or equal to 10% at screening BMI more than or equal to 23kg/m2 cardiovascular disease with onset more than or equal to month prior to screening.
排除标准
- •Exclusion Criteria: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 NYHA class IV heart failure or post-transplantation cardiomyopathy severely impaired renal function.
结局指标
主要结局
Time to first occurrence of any component of a cardiovascular composite endpoint (CV death, MI, stroke, resuscitated cardiac arrest, hospitalization for unstable angina or hospitalization for heart failure)
时间窗: Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
次要结局
- Secondary cardiovascular composite endpoints,Individual components of primary cardiovascular composite endpoints, Total mortality,Metabolic and renal function parameters: HbA1c, fasting plasma glucose, body weight, lipid profile, ACR, albuminuria, GFR(weeks 1,4,12 and every 3 to 4 months thereafter)