EUCTR2016-001580-37-AT进行中（未招募）1 期
Empagliflozin in Post-Transplantation Diabetes Mellitus - EMPTRA-PTDM
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
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
- •Diagnosed PTDM defined as:
- •2 hour plasma glucose level = 200 mg/dL in the OGTT (75mg glucose), twice blood glucose levels = 200 mg/dL during random controls or twice fasting glucose levels = 125 mg/dL or HbA1c = 6.5%
- •Stable graft function for more than 6 months post transplantation (eGFR = 30 ml/min)
- •At least 6 months of basal insulin therapy for PTDM
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Age< 18 years
- •Patients with prior history of type 1 or type 2 diabetes
- •Severe renal impairment (GFR < 30 mL/min./1.73 m2)
- •Severe blood glucose elevation with the need for therapy with insulin > 40 IE/day or HbA1c >8.5%.
研究者
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