CTRI/2017/02/007841已完成3 期
Cardiovascular outcomesA trial investigating the cardiovascular safety of oral semaglutide insubjects with type 2 diabetes
ovo Nordisk India Private Ltd0 个研究点目标入组 201 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
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. Informed consent obtained before any trial-related activities. Trial-related activities are any
- •procedures that are carried out as part of the trial, including activities to determine suitability
- •for the trial.
- •2. Male or female diagnosed with type 2 diabetes.
- •3. Age >= 50 years at screening and at least one of the below conditions:
- •a. prior myocardial infarction
- •b. prior stroke or transient ischaemic attack (TIA)
- •c. prior coronary, carotid or peripheral arterial revascularisation
- •d. > 50% stenosis on angiography or imaging of coronary, carotid or lower
- •extremity arteries
- •e. history of symptomatic coronary heart disease documented by e.g. positive
- •exercise stress test or any cardiac imaging or unstable angina pectoris with ECG
- •f. asymptomatic cardiac ischaemia documented by positive nuclear imaging test or
- •exercise test or stress echo or any cardiac imaging
- •g. chronic heart failure New York Heart Association (NYHA) class II-III
- •h. moderate renal impairment (corresponding to an estimated glomerular filtration
- •rate (eGFR) between 30-59 mL/min/1.73 m2)
- •Age >= 60 years at screening and at least one of the below risk factors:
- •i. microalbuminuria or proteinuria
- •j. hypertension and left ventricular hypertrophy by ECG or imaging
- •k. left ventricular systolic or dysfunction by imaging l. ankle/brachial index < 0.9
排除标准
- •1. Known or suspected hypersensitivity to the trial product or related products.
- •2. Previous participation in this trial. Participation is defined as signed informed consent. 3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing
- •potential and not using adequate contraceptive methods (adequate contraceptive measures as
- •required by local regulation or practice. Local country regulations or practices are specified
- •in section 8 of the protocol).
- •4. Receipt of any investigational medicinal product within 90 days before screening.
- •For Brazil only: Participation in other clinical trials within one year prior to screening
- •unless there is a direct benefit to the research subject at the investigator´s discretion.
- •5. Participation in another clinical trial of an investigational medicinal product. Participation in
- •a clinical trial which evaluate stent(s) is allowed.
- •6. Current or previous (within 90 days prior to screening) treatment with any GLP-1 receptor
- •agonist, DPP-4 inhibitor or pramlintide.
- •7. Any disorder, which in the investigatorâ??s opinion might jeopardise subjectâ??s safety or
- •compliance with the protocol.
- •8. Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary
- •thyroid carcinoma (MTC).
- •9. History of pancreatitis (acute or chronic).
- •10. History of major surgical procedures involving the stomach potentially affecting absorption
- •of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass
- •11. Subjects presently classified as being in New York Heart Association (NYHA) Class IV
- •heart failure.
- •12. Planned coronary, carotid or peripheral artery revascularisation known on the day of
- •13. Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or
- •transient ischaemic attack within the past 60 days prior to screening.
- •14. Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment
- •(corresponding to eGFR <30 mL/min/1.73 m2).
- •15. History or presence of malignant neoplasms within the last 5 years (except basal and
- •squamous cell skin cancer and carcinoma in situ).
- •16. History of diabetic ketoacidosis.
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