CTRI/2019/08/020910进行中（未招募）3 期
Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes - SO
ovo Nordisk0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female, age =50 years 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).a
- •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. =50% stenosis in coronary artery documented by cardiac catheterisation or CT
- •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. =50% stenosis in carotid artery documented by X-ray angiography, MR
- •angiography, CT 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 a =50% stenosis in peripheral artery (excluding
- •carotid) documented by X-ray angiography, MR angiography, CT 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 b
排除标准
- •1. Known or suspected hypersensitivity to trial product or related products.
- •2. Previous participation in this trial. Participation is defined as randomisation.
- •3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing
- •potential and not using a highly effective contraceptive method.
- •4. Participation in any clinical trial of an approved or non-approved investigational medicinal
- •product within 30 days before screening.
- •5. Any disorder, which in the investigator’s opinion might jeopardise patient’s safety or
- •compliance with the protocol.
- •6. 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
- •7. Planned coronary, carotid or peripheral artery revascularisation.
- •8. Heart failure presently classified as being in New York Heart Association (NYHA) Class IV.
- •9. Treatment with any GLP-1 receptor agonist (RA) within 30 days before screening.
- •10. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus
- •examination performed within the past 90 days prior to screening or in the period between
- •screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a
- •digital fundus photography camera specified for non-dilated examination.
- •11. Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal
- •and squamous cell skin cancer and any carcinoma in-situ is allowed.
- •12. Personal or first degree relative(s) history of MEN2 or MTC.
- •13. End stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis.
- •14. History of major surgical procedures involving the stomach or small intestine potentially
- •affecting absorption of drugs and or nutrients, as judged by the investigator.
研究者
相似试验
进行中（未招募）
1 期
A heart disease study of semaglutide in patients with type 2 diabetesMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 2EUCTR2018-003141-42-SKovo Nordisk A/S9,642
进行中（未招募）
1 期
A heart disease study of semaglutide in patients with type 2 diabetesDiabetes Mellitus, Type 2EUCTR2018-003141-42-FRovo Nordisk A/S9,642
进行中（未招募）
1 期
A heart disease study of semaglutide in patients with type 2 diabetesDiabetes Mellitus, Type 2EUCTR2018-003141-42-GBovo Nordisk A/S9,642
进行中（未招募）
1 期
A heart disease study of semaglutide in patients with type 2 diabetesDiabetes Mellitus, Type 2EUCTR2018-003141-42-ESovo Nordisk A/S9,642
进行中（未招募）
1 期
A heart disease study of semaglutide in patients with type 2 diabetesMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 2EUCTR2018-003141-42-CZovo Nordisk A/S9,642