EUCTR2013-003050-25-FR进行中（未招募）1 期
A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5,700
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. Must have a diagnosis of type 2 diabetes mellitus.
- •2. Must have inadequate diabetes control (as defined by glycosylated hemoglobin level >=7.0% to <=10.5% at screening)
- •3. History or high risk of CV events.
- •4. Must be either not on antihyperglycemic agents (AHA) therapy, or on AHA monotherapy, or combination AHA therapy with any approved agent for the control of blood glucose levels.
- •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 3420
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2280
排除标准
- •1. History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
- •2. History of one or more severe hypoglycemic episode within 6 months before screening.
- •3. History of hereditary glucose-galactose malabsorption or primary renal glucosuria.
- •4. Ongoing, inadequately controlled thyroid disorder.
- •5. Renal disease that required treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant
- •6. Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening.
研究者
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