NL-OMON47856已完成3 期
A double blind placebo controlled study to evaluate the effects of bexagliflozin on hemoglobin A1c in patients with type 2 diabetes and increased risk of cardiovascular adverse events - Theracos study THR-1442-C-476
Theracos Sub, LLC0 个研究点目标入组 132 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
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
- 年龄范围
- 18 至 99（—）
入选标准
- •The study population will include:
- •1. Male or female adult subjects with an age *40 years
- •2. Subjects with a diagnosis of T2DM
- •3. Subjects with HbA1c values of 7.5 * 11%, inclusive
- •4. Subjects with fasting plasma glucose (FPG) * 250 mg/dL at screening
- •5. Subjects who have a regimen for treatment of T2DM that has been stable for
- •the past 3 months. A stable regimen is defined as: no changes in dose or
- •frequency of OHAs or GLP-1 agonists, or <20% variability in total daily insulin
- •6. Subjects who present with at least one of the following 3 histories:
- •Group 1: A history of atherosclerotic vascular disease as defined by one or
- •more of the following:
- •a) myocardial infarction (MI) or ischemic (non-hemorrhagic) stroke > 3 months
- •but * 5 years prior to screening or
- •b) documented history of coronary, carotid, or peripheral arterial
- •revascularization (coronary artery bypass grafting must have occurred * 5 years
- •prior to screening)
- •Group 2: A history of NYHA class II or class III heart failure at the time of
- •screening with a left ventricular ejection fraction (LVEF) * 40% and no
- •subsequent LVEF > 40% documented within 6 months of screening. No more than 200
- •subjects with class II NYHA heart failure will be randomized in the study
- •Group 3: Age * 55 years with 2 or more of the following:
- •a) diabetes duration of * 10 years
- •b) uncontrolled hypertension defined as SBP > 140 mmHg despite 3 or more
- •anti-hypertensive medications
- •c) current smoking
- •d) urine albumin:creatinine ratio (UACR) > 30 mg/g
- •e) eGFR of 45 to 60 mL/min/1.73 m2, or
- •f) HDL < 1 mmol/L (38 mg/dL)
- •7. Female subjects of childbearing potential who are willing to use an adequate
- •method of contraception and to not become pregnant for the duration of the
- •study. Adequate contraceptive measures include, but are not limited to, oral
- •contraceptives, intrauterine devices, Depo-Provera, Norplant, hormonal
- •contraceptive implants, bilateral tubal ligation, partner with vasectomy,
- •condom or diaphragm plus contraceptive sponge, foam, or jelly, and abstinence
- •8. Subjects who are willing and able to return for all clinic visits and to
- •complete all study required procedures, including self-monitored blood glucose
- •(SMBG) measurement, and take run-in medication, missing no more than one dose
- •9. Subjects who receive anti-hypertensive medications at a stable dosage for *
- •2 weeks prior to randomization
- •10. Subjects who receive lipid modifying therapy on a stable regimen for 6
- •weeks prior to randomization
- •11. Subjects who have seated SBP < 170 mmHg and DBP < 110 mmHg at screening
排除标准
- •Patients who exhibit any of the following characteristics will be excluded from
- •1. Diagnosis of type 1 diabetes mellitus or maturity*onset/diabetes of the
- •young (MODY)
- •2. Hemoglobinopathy that affects HbA1c measurement
- •3. Frequent symptomatic hypoglycemia (greater than one episode per week on
- •4. Genitourinary tract infection within 6 weeks of screening or history of * 3
- •genitourinary infections requiring treatment within the last 6 months
- •5. Cancer, active or in remission for < 3 years (Non-melanoma skin cancer or
- •basal cell carcinoma or carcinoma in situ of the cervix will not be grounds for
- •6. History of alcohol or illicit drug abuse in the past 2 years
- •7. Evidence of abnormal liver function tests (total bilirubin or alkaline
- •phosphatase > 1.5 x upper limit of normal (ULN) with the exception of isolated
- •Gilbert*s syndrome); or alanine aminotransferase (ALT) or aspartate
- •aminotransferase (AST) > 2.5 x ULN
- •8. History of MI, stroke or hospitalization for heart failure in the prior 3
- •9. Evidence of NYHA class IV heart failure at screening or randomization
- •10. Presently scheduled for percutaneous coronary intervention, coronary artery
- •bypass grafting or any surgical procedure
- •11. Previous treatment with bexagliflozin or EGT0001474
- •12. Currently or within 3 months of taking any SGLT2 inhibitors
- •13. Any condition, disease, disorder, or clinically relevant laboratory
- •abnormality that, in the opinion of the PI, would jeopardize the subject*s
- •appropriate participation in this study or obscure the effects of treatment
- •14. Prior renal transplantation or evidence of nephrotic syndrome, defined as a
- •urine albumin: creatinine ratio (UACR) > 2000 mg/g, at screening
- •15. Implantation of a cardiac resynchronization therapy device within 3 months
- •prior to screening or intent to implant a cardiac resynchronization therapy
- •(CRT) within 6 months following screening
- •16. Diagnosis of peripartum or chemotherapy-induced cardiomyopathy within 12
- •months prior to screening
- •17. Symptomatic bradycardia or second or third degree atrioventricular block
- •without a pacemaker
- •18. eGFR, as calculated by the modification of diet in renal disease study
- •equation (MDRD), < 45 mL/min/1.73 m2 or requiring dialysis
- •19. Pregnant or nursing
- •20. Currently participating in another interventional trial
研究者
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