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临床试验/EUCTR2009-017136-40-DE
EUCTR2009-017136-40-DE进行中(未招募)不适用

A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week, Multicenter Study With a 26-Week Extension, to Evaluate the Efficacy, Safety and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

Janssen Cilag international NV0 个研究点目标入组 240 人开始时间: 2010年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
240

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 with T2DM not on an AHA or on any AHA in monotherapy or combination therapy (including oral or non oral agents)
  • Patients with reduced kidney function
  • 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 168
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 72

排除标准

  • History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
  • Have proliferative diabetic retinopathy for which treatment is planned during the course of the study
  • Kidney disease that required treatment with immunosuppressive therapy, history of dialysis or kidney transplant, presence of nephrotic syndrome (eg, severe proteinuria with hypoalbuminemia and/or edema), or inflammatory kidney disease
  • Receiving anti hypertensive or anti-hyperlipidemic therapy not on a stable regimen
  • History of a severe hypoglycemic episode within 6 months before screening

研究者

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