EUCTR2013-002518-11-SK进行中（未招募）1 期
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS CARDIOVASCULAR OUTCOMES FOLLOWING TREATMENT WITH ERTUGLIFLOZIN (MK-8835/PF-04971729) IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED VASCULAR DISEASE, THE VERTIS CV STUDY
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 8,000
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
入选标准
- •1. Subjects = 40 years of age at the time of the initial Screening visit
- •(V1) with a diagnosis of T2DM in accordance with American Diabetes
- •Association (ADA) guidelines.
- •2. HbA1c at the Screening visit (V1) of 7.0 10.5% (53 91 mmol/mol) on
- •stable allowable AHA(s) or on no background AHA for at least 8 weeks
- •prior to the Screening visit (V1).
- •3. Body Mass Index (BMI) =18.0 kg/m2.
- •4. Subjects must have evidence or a history of atherosclerosis involving
- •the coronary, cerebral or peripheral vascular systems as follows (must
- •have at least one of the following a-d):
- •a. Coronary artery disease as indicated by a history of presumed
- •spontaneous myocardial infarction (hospitalized with final diagnosis of
- •myocardial infarction, excluding peri-procedural or definite secondary
- •myocardial infarction [eg, due to profound anemia or hypertensive
- •emergency, troponin increase in sepsis] in which the most recent event
- •occurred at least 3 months (90 days) prior to the Screening visit (V1);
- •b. Coronary artery disease as indicated by a history of coronary
- •revascularization through either a Percutaneous Coronary Intervention
- •(PCI) at least 3 months (90 days) prior to the Screening visit (V1) or
- •Coronary Artery Bypass Graft (CABG) at least 3 months (90 days) prior
- •to the Screening visit (V1); OR
- •c. Ischemic (presumed thrombotic) cerebrovascular disease as indicated
- •by a history of ischemic stroke (hospitalized with a final diagnosis of non
- •hemorrhagic stroke [includes completion of a standard evaluation for
- •stroke in an acute care facility or stroke clinic without hospital
- •admission] with the most recent event occurring at least 3 months (90
- •days) prior to the Screening visit (V1) or a history of carotid
- •revascularization at least 3 months (90 days) prior to the Screening visit
- •d. Peripheral arterial disease as indicated by:
- •1. Angiographically documented peripheral vascular disease; or
- •2. Resting ankle/brachial index (ABI) of <0.85 (measured by a certified
- •vascular laboratory) plus symptoms of claudication; or
- •3. Amputation, peripheral bypass, or peripheral angioplasty of the
- •extremities secondary to ischemia occurring at least 3 months (90 days)
- •prior to the Screening visit (V1).
- •5. There is adequate documentation of the objective evidence that the
- •subject has established vascular disease such as investigational site's
- •medical records, copies of such records from other institutions, or a
- •letter from a referring physician that specifically states the diagnosis
- •and date of the most recent occurrence of the qualifying event(s) or procedure(s).
- •6. Subject meets one of the following criteria (a, b or c):
- •a. Is a male;
- •b. Is a female not of reproductive potential defined as one who (See
- •Section 4.4.4.1 and Section 4.4.4.2 for refe
排除标准
- •1. Subjects who had been previously randomized into this trial.
- •2. Subjects experiencing a cardiovascular event (eg, myocardial
- •infarction or stroke) or undergoing coronary angioplasty or peripheral
- •intervention procedure between the Screening visit (V1) and
- •randomization.
- •3. Subjects undergoing any cardiovascular surgery (eg, valvular surgery)
- •within 3 months (90 days) of the Screening visit (V1).
- •4. Subjects with any planned coronary revascularization or peripheral
- •intervention procedure or other cardiovascular surgery.
- •5. Subjects with New York Heart Association (NYHA) Class IV heart
- •failure at the Screening visit (V1).
- •6. Mean value for triplicate screening sitting systolic blood pressure
- •>160 mm Hg and/or diastolic blood pressure >90 mm Hg after at least a
- •5 minute seated rest at the Screening visit (V1), confirmed via 1 repeat triplicate set at the Screening visit (V1) if deemed necessary. For
- •subjects with a mean triplicate value of sitting systolic blood pressure
- •>160 mm Hg and/or diastolic blood pressure >90 mm Hg after at least a
- •5 minute seated rest at the Screening visit (V1) the investigator or the
- •treating physician is allowed to adjust background blood pressure
- •medication(s) to lower blood pressure values in order for the subject to
- •be re-assessed for enrollment eligibility.
- •7. Subject has a clinically significant ECG abnormality at Screening visit
- •(V1) that requires further diagnostic evaluation or intervention.
- •8. History of type 1 diabetes mellitus or a history of ketoacidosis.
- •9. History of other specific types of diabetes (eg, genetic syndromes,
- •secondary pancreatic diabetes, diabetes due to endocrinopathies, drug-
- •or chemical induced, and post organ transplant).
- •10. Subject has active, obstructive uropathy or indwelling urinary
- •11. Subject has a history of malignancy =5 years prior to signing
- •informed consent, except for adequately treated basal cell or squamous
- •cell skin cancer or in situ cervical cancer.
- •Note (1) A subject with a history of malignancy <=5 years prior to
- •signing informed consent should have no evidence of residual or
- •recurrent disease.
- •Note (2) A subject with any history of melanoma, leukemia, lymphoma,
- •or renal cell carcinoma is excluded.
- •12. Subject routinely consumes >2 alcoholic drinks per day or >14
- •alcoholic drinks per week, or engages in binge drinking.
- •Note (1): One alcoholic drink is defined as 5 oz (150 mL) of wine, or 12
- •oz (350 mL) of beer, or 1.5 oz (50 mL) of 80 proof liquor.
- •Note (2): Binge drinking is defined as a pattern of 5 or more alcoholic
- •drinks (male), or 4 or more alcoholic drinks (female) in about 2 hours.
- •13. Any clinically significant malabsorption condition.
- •14. Subjects with a known hypersensitivity or intolerance to any SGLT2
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