Double Blind Comparison Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics With Metformin
试验速览
- 阶段
- 4 期
- 入组人数
- 1,054
- 试验地点
- 1
- 主要终点
- New onset of hypertension
研究概览
简要总结
Objectives:
Primary
- Primary prevention of new onset of hypertension
Secondary
- Reduction of 24h BP in type II diabetics with prehypertension
- Reduction of non dipping status, day and nighttime BP, morning BP surge in subjects receiving EMPAGLIFLOZIN
- Reduction in the total cardiovascular risk
- 3 years morbidity and mortality rates
- Arterial de-stiffening, reduction in central aortic blood pressure in subjects receiving EMPAGLIFLOZIN
详细描述
Study rationale: The majority of patients with diabetes are having higher blood pressure than optimal. More than 30% of patients with type II diabetes are prehypertensives with systolic blood pressure between 130 and 140 mmHg. If a drug for diabetes has an impact on blood pressure in such patients then this drug will reduce cardiovascular risk beyond the reduction on glucose levels. There are some evidence that EMPAGLIFLOZIN is reducing blood pressure levels but a comprehensive study is not available.
Timelines and Study duration:
Start date : 01-01-2016 End date : 01-01-2019 Clinical Study Report date: June 2018 Publication date: 2018, 2018, 2019,2020
Methodology:
Inclusion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（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
Metformin
527 Patients treated with Metformin 850x2mg titrated to 1000x2mg Daily oral
干预措施: Metformin (Drug)
Empagliflozin
527 Patients treated with empagliflozin 10mg titrated to 25 mg Daily oral
干预措施: empagliflozin (Drug)
结局指标
主要结局
New onset of hypertension
时间窗: 36 months
次要结局
- 24h blood pressure levels(36 months)
- Total cardiovascular risk(36 months)
- Arterial stiffness(36 months)
- Central aortic blood pressure(36 months)
- Mortality cardiovascular(36 months)
- Morbidity cardiovascular(36 months)
研究者
Vasilios Kotsis
Prof. Med
Aristotle University Of Thessaloniki