EUCTR2019-002735-28-RO进行中（未招募）1 期
The Effect of Tirzepatide versus Dulaglutide on Major AdverseCardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT) - SURPASS-CVOT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12,500
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] Men or women at least 40 years old with a diagnosis of T2DM (WHO
- •[2] Established CVD, including at least 1 of the following (a-c):
- •a. Coronary artery disease (CAD) with EITHER of the following:
- •- Documented history of spontaneous MI
- •- =50% stenosis in 1 or more major coronary arteries, determined by
- •invasive angiography
- •- =50% stenosis in 2 or more major coronary arteries, determined by
- •computed tomography coronary angiography (CTCA), or
- •- History of surgical or percutaneous coronary revascularization
- •b. Cerebrovascular disease – ANY of the following:
- •- Documented history of ischemic stroke
- •- Carotid arterial disease with =50% stenosis, documented by carotid
- •ultrasound, magnetic resonance imaging (MRI), or angiography
- •- Carotid stenting or surgical revascularization;
- •c. Peripheral arterial disease with EITHER of the following:
- •- Intermittent claudication and ankle-brachial index <0.9
- •- Prior nontraumatic amputation or peripheral vascular procedure (eg,
- •stenting or surgical revascularization), due to peripheral arterial
- •[3] HbA1c =7% (=53 mmol/mol) and =10.5% (=91.3 mmol/mol) based
- •on central laboratory assessment at screening.
- •[4] Body mass index (BMI) =25 kg/m2.
- •[5] At the time of signing the informed consent: Contraceptive use by
- •men or women should be consistent with local regulations regarding the
- •methods of contraception for those participating in clinical trials.
- •[6] In the investigator's opinion, patients are well motivated, capable,
- •and willing to learn how to self-inject treatment (tirzepatide or
- •dulaglutide), as required for this protocol (visually impaired persons
- •and/or persons with physical limitations who are not able to perform the
- •injections must have the assistance of an individual trained to inject the
- •study drug).
- •[7] Patients are capable of giving signed informed consent.
- •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 6250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6250
排除标准
- •[8] Have type 1 diabetes mellitus.
- •[9] Have uncontrolled diabetes requiring immediate therapy (such as
- •diabetic ketoacidosis) at screening or randomization, in the judgment of
- •the physician.
- •[10] Have had 1 or more events of severe hypoglycemia and/or 1 or
- •more events of hypoglycemia unawareness within 6 months prior to
- •[11] Have a history of proliferative retinopathy or macular edema. A
- •dilated fundoscopic exam, evaluated by an eye care professional
- •(ophthalmologist or optometrist) is required to confirm eligibility. In
- •addition, nonproliferative diabetic retinopathy that requires acute
- •treatment according to the opinion of the investigator is also excluded.
- •[12] Have been hospitalized for CHF within 2 months prior to screening.
- •[13] Have chronic New York Heart Association Functional Classification
- •[14] Are currently planning a coronary, carotid, or peripheral artery
- •revascularization.
- •[15] Had chronic or acute pancreatitis any time prior to screening,
- •irrespective of etiology.
- •[16] Have a known clinically significant gastric emptying abnormality
- •(eg, severe diabetic gastroparesis or gastric outlet obstruction), have
- •undergone gastric bypass (bariatric) surgery or restrictive bariatric
- •surgery (eg, Lap-Band®, vertical sleeve gastrectomy), or chronically
- •take drugs that directly affect GI motility.
- •[17] Have acute or chronic hepatitis, signs or symptoms of any other
- •liver disease, or an alanine aminotransferase (ALT) level =3X the upper
- •limit of normal (ULN) for the reference range, as determined by the
- •central laboratory.
- •[18] Have known chronic severe renal failure (defined as a known eGFR
- •<15 mL/minute/1.73 m2) or are on chronic dialysis.
- •[19] Have evidence of a significant, uncontrolled endocrine abnormality
- •(eg, thyrotoxicosis or adrenal crises).
- •[20] Have a family or personal history of multiple endocrine neoplasia
- •type 2 (MEN2) or familial medullary thyroid carcinoma (MTC) or personal
- •history of nonfamilial MTC.
- •[21] Have a serum calcitonin level at screening of: (based on central
- •laboratory results)
- •- =20 ng/L at Visit 1, if eGFR =60 mL/min/1.73 m2, or
- •- =35 ng/L at Visit 1, if eGFR <60 mL/min/1.73 m2.
- •[22] Have a history of an active or untreated malignancy or are in
- •remission from a clinically significant malignancy for less than 5 years.
- •An exception for this criterion is basal or squamous cell skin cancer, in
- •situ carcinomas of the cervix, or in situ prostate cancer.
- •[23] Have a history of any other condition (such as known drug or
- •alcohol abuse or psychiatric disorder) that, in the opinion of the
- •investigator, may preclude the patient from following and completing the
- •[24] Have had a transplanted organ (corneal transplants [keratoplasty]
- •allowed) or awaiting an organ transplant.
- •[25] Have any other condition (eg, hypersensitivity) that is a
- •contraindication to any incretin or GLP-1 RAs.
- •[26] Have had an MI, surgical or percutaneous coronary
- •revascularization procedure, ischemic stroke, carotid stenting or surgical
- 另有 8 项未显示
研究者
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