EUCTR2017-002644-32-EE进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function
exicon Pharmaceuticals, Inc.0 个研究点目标入组 16,154 人开始时间: 2017年11月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16,154
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
- •-Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) = 7%.
- •-Estimated glomerular filtration rate (eGFR) = 25 and = 60 mL/min/1.73 m2.
- •-Age 18 years or older with at least one major cardiovascular risk factor or age 55 years or older with at least two minor cardiovascular risk factors.
- •-Signed written 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 9700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6454
排除标准
- •-Antihyperglycemic treatment has not been stable within 12 weeks prior to screening.
- •-Planned coronary procedure or surgery after randomization.
- •-Lower extremity complications (such as skin ulcer, infection, osteomyelitis, and gangrene) identified during screening and requiring treatment at randomization.
- •-Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during the study.
研究者
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