EUCTR2010-023799-21-BG进行中（未招募）1 期
The Effect of Dulaglutide on Major Cardiovascular Events inPatients with Type 2 Diabetes: Researching CardiovascularEvents with a Weekly INcretin in Diabetes (REWIND) - REWIND
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 9,901
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
- •Patients are eligible to be included in the study only if they meet all of
- •the following criteria:
- •[1] Men or women with type 2 diabetes based on:
- •a) a previous diagnosis of type 2 diabetes; or
- •b) newly detected type 2 diabetes based on the American Diabetes
- •Association criteria (ADA 2011) as either two of the following criteria or
- •one of the following criteria that is confirmed on a second day:
- •- fasting plasma glucose =7.0 mmol/L (126 mg/dL), or
- •- 2-hour plasma glucose =11.1 mmol/L (200 mg/dL) following a
- •75-gram oral glucose load, as described by the World Health
- •Organization (WHO 2006), or
- •- HbA1c =6.5% (=48 mmol/mol)
- •[2] HbA1c value of =9.5% (=81 mmol/mol) at screening
- •[3] Are taking:
- •a) no glucose-lowering drugs; OR
- •b) 1 or 2 classes of oral glucose-lowering drugs; with or without basal
- •insulin daily [as defined below in (d)]; if one of the oral glucoselowering
- •drugs is a DPP-IV inhibitor, the patient must be willing to stop
- •the DPP-IV inhibitor after eligibility is confirmed; OR
- •c) 1 or 2 classes of oral glucose-lowering drugs with a GLP-1 analog;
- •with or without basal insulin daily [as defined below in (d)]; the patient
- •must be willing to stop the GLP-1 analog after eligibility is confirmed; OR
- •d) basal insulin daily defined as 1 to 2 injections per day of either
- •glargine, detemir, neutral protamine Hagedorn (NPH), or another
- •approved basal insulin.
- •[4] No change in the number or class of glucose-lowering drugs, no
- •change in excess of doubling or halving the dose of these drugs, and if
- •on insulin, no change in the dose of insulin in excess of 20% of the
- •average daily dose, for at least 3 months before screening
- •[5] If age =50 years and established clinical vascular disease defined as
- •1 or more of the following:
- •- a history of MI
- •- a history of ischemic stroke
- •- a history of coronary, carotid, or peripheral artery revascularization. If
- •prior coronary artery bypass grafting (CABG), the CABG should have
- •been performed >2 years prior to randomization. If prior carotid or
- •peripheral artery revascularization, the revascularization should have
- •been performed >2 months prior to randomization.
- •- hospitalization for unstable angina with ECG changes (new or
- •worsening ST or T wave changes), or myocardial ischemia on imaging, or
- •need for percutaneous coronary intervention (PCI);
- •If age =55 years and subclinical vascular disease defined as 1 or more of
- •the following:
- •- a history of myocardial ischemia by a stress test or with cardiac
- •imaging, with or without history of exertional angina
- •- >50% vascular stenosis with imaging of the coronary, carotid, or lower
- •extremity arteries, with or without claudication history
- •- ankle-brachial index <0.9
- •- 2 consecutive values or a documented history of persistent eGFR<60
- •mL/minute/1.73m2
- 另有 14 项未显示
排除标准
- •Patients will be excluded from the study if they meet any of the
- •following criteria:
- •[1] Uncontrolled diabetes requiring immediate therapy (such as diabetic
- •ketoacidosis) at screening or randomization, in the judgment of the
- •[2] Have experienced a severe hypoglycemic episode within 1 year prior
- •to randomization.
- •[3] Have experienced an acute coronary or cerebrovascular event within
- •2 months prior to randomization.
- •[4] Are currently planning a coronary, carotid, or peripheral artery
- •revascularization.
- •[5] Have known chronic renal failure (defined as a known eGFR <15
- •mL/minute/1.73m2) or are on chronic dialysis at screening.
- •[6] Have a known clinically significant gastric emptying abnormality (for
- •example, severe diabetic gastroparesis or gastric outlet obstruction) or
- •have undergone gastric bypass (such as bariatric) surgery.
- •[7] Have a past history of chronic, acute, or idiopathic pancreatitis or
- •signs/symptoms of pancreatitis.
- •[8] Have severe hepatic dysfunction such as portal hypertension or
- •cirrhosis, acute or chronic hepatitis, signs or symptoms of any other liver
- •disease, or an alanine transaminase (ALT) level =3.0 times the upper
- •limit of normal (ULN) for the reference range at screening.
- •[9] Have a) any self or family history of medullary C-cell hyperplasia,
- •focal hyperplasia, carcinoma (including sporadic, familial or part of
- •multiple endocrine neoplasia MEN 2A or 2B syndrome), or
- •b) any known self or family history of type 2A or type 2B multiple
- •endocrine neoplasia (MEN 2A or 2B) in the absence of known C-cell
- •hyperplasia. This includes patients with a family history of MEN 2A or 2B
- •whose family history for the syndrome is RET negative. The only
- •exception for this exclusion will be patients whose family members with
- •MEN 2A or 2B have a known RET mutation and the potential patient for
- •the study is negative for that RET mutation.
- •[10] Have a calcitonin value =20 pg/mL according to the central
- •laboratory measurement at screening.
- •[11] Are previous organ transplant recipients or are awaiting an organ
- •transplant (corneal transplants [keratoplasty] are allowed).
- •[12] Are taking a weight loss drug (over-the-counter or prescription) and are unwilling or unable to discontinue the drug at the time of
- •screening or are taking pramlintide at the time of screening.
- •[13] History of, an active, or untreated malignancy, in remission from a
- •clinically significant malignancy (other than basal or squamous cell skin
- •cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for
- •less than 5 years prior to, or are receiving or planning to receive therapy
- •for cancer, at screening.
- •[14] Females who are pregnant or have a positive pregnancy test at
- •screening, or who have given birth within the past 90 days, or who are
- •breastfeeding.
- •[15] Females of childbearing potential (that is, females who are between
- •menarche and less than 1-year past the last menses with an intact
- •uterus) who do not agree to use a reliable method of birth control during
- •the study and for 1 month following the last dose of study drug.
- •Menopause is the absence of menses for =1 year and/or surgically or
- 另有 6 项未显示
研究者
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