JPRN-jRCT2080223076已完成2 期
An Exploratory Phase 2/3, Randomized, Double-blind, Placebo Controlled, Parallel Design Study to Evaluate the Efficacy, Safety and Pharmacodynamics of Dapagliflozin and Dapagliflozin in Combination With Saxagliptin in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria Treated With ACEi or ARB
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 75
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Provision of informed consent prior to any study specific procedures
- •- History of type 2 diabetes mellitus for more than 12 months
- •- HbA1c 7.0% or more and less than 11.0%
- •- Stable antidiabetic treatment during the last 12 weeks up to randomization
- •- eGFR 25-75mL/minute/1.73m2, inclusive
- •- Micro or macroalbuminuria (UACR 30 - 3500mg/g)
- •- Treatment with ACE inhibitor or an ARB for at least 3 months prior to screening
- •- Body mass index between 20 and 45kg/m2
排除标准
- •- Any of the following CV/Vascular Diseases within 3 month prior to signing the consent at Visit 1
- •- Myocardial infarction
- •- cardiac surgery or revascularization (CABG/PTCA)
- •- unstable angina
- •- unstable HF
- •- New York Heart Association (NYHA) Class III-IV
- •- transient ischemic attack (TIA) or significant cerebrovascular disease
- •- unstable or previously undiagnosed arrhythmia
- •- Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency
- •- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3X ULN
- •- Total Bilirubin (TB) >2mg/dL (34.2 micro mol/L)
- •- History of acute kidney injury requiring renal replacement therapy (dialysis or ultrafiltration) or any biopsy or imaging verifying intercurrent kidney disease other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis
- •- Ongoing treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors
- •- Any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant
- •risk to the patient or patient suspected or with confirmed poor protocol or medication compliance
研究者
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