A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7,064
- 试验地点
- 615
- 主要终点
- Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke.
研究概览
简要总结
The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.
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
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 10773 low dose
BI 10773 tablets once daily
干预措施: Placebo BI 10773 high dose (Drug)
BI 10773 low dose
BI 10773 tablets once daily
干预措施: BI 10773 low dose (Drug)
BI 10773 high dose
BI 10773 tablets once daily
干预措施: BI 10773 high dose (Drug)
BI 10773 high dose
BI 10773 tablets once daily
干预措施: Placebo BI 10773 low dose (Drug)
Placebo
Placebo tablets matching BI 10773
干预措施: Placebo BI 10773 high dose (Drug)
Placebo
Placebo tablets matching BI 10773
干预措施: Placebo BI 10773 low dose (Drug)
结局指标
主要结局
Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke.
时间窗: From randomisation to individual end of observation, up to 4.6 years
Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke. Percentage of patients with the event are presented.
次要结局
- Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated)(From randomisation to individual end of observation, up to 4.6 years)
- Percentage of Participants With New Onset Albuminuria(From randomisation to individual end of observation, up to 4.6 years)
- Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris(From randomisation to individual end of observation, up to 4.6 years)
- Percentage of Participants With Silent MI(From randomisation to individual end of observation, up to 4.6 years)
- Percentage of Participants With New Onset Macroalbuminuria(From randomisation to individual end of observation, up to 4.6 years)
- Percentage of Participants With the Composite Microvascular Outcome(From randomisation to individual end of observation, up to 4.6 years)