EUCTR2018-003141-42-IT进行中（未招募）1 期
Semaglutide cardiovascular outcomes trial in patients with type 2 diabetes - SO
OVO NORDISK. S.P.A.0 个研究点目标入组 9,642 人开始时间: 2021年6月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9,642
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female, age 50 years or older at the time of signing informed consent.
- •2. Diagnosed with type 2 diabetes mellitus
- •3. HbA1c 6.5% - 10.0% (47 - 86 mmol/mol) (both inclusive) (latest available and no more than 30 days old local laboratory assessment based on medical records or point of care measurement)
- •4. At least one of the below conditions (a-d):
- •a) Coronary heart disease defined as at least one of the following:
- •i. Prior myocardial infarction
- •ii. Prior coronary revascularisation procedure
- •iii. Equal to or above 50% stenosis in coronary artery documented by cardiac catheterisation, computerizede tomography coronary angiography
- •iv. Coronary heart disease with ischaemia documented by stress test with any imaging modality
- •b) Cerebrovascular disease defined as at least one of the following:
- •i. Prior stroke
- •ii. Prior carotid artery revascularisation procedure
- •iii. Equal to or above 50% stenosis in carotid artery documented by X-ray angiography, magnetic resonance angiography, computerizede tomography angiography or Doppler ultrasound
- •c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following:
- •i. Intermittent claudication with an Ankle-brachial index (ABI) < 0.85 at rest
- •ii. Intermittent claudication with an equal to or above 50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, magnetic resonance angiography, computerizede tomography angiography or Doppler ultrasound
- •iii. Prior peripheral artery (excluding carotid) revascularization procedure
- •iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis)
- •d) Chronic kidney disease defined as:
- •i. eGFR < 60 mL/min/1.73 m2 (Based on medical records using latest available and no more than 6 months old assessment).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3857
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5785
排除标准
- •1. Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack (TIA) within the past 60 days prior to the day of screening
- •2. Planned coronary, carotid or peripheral artery revascularisation.
- •3. Heart failure presently classified as being in New York Heart Association (NYHA) Class IV.
- •4. Treatment with any GLP-1 receptor agonist (RA) within 30 days before screening.
研究者
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