EUCTR2015-000804-24-SE进行中（未招募）1 期
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III study to Evaluate the Glycemic Efficacy and Renal Safety of dapagliflozin in patients with Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) who have Inadequate Glycemic Control
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 302
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. Female or male aged =18 years and <75 years.
- •2. History of T2DM for more than 12 months.
- •3. Inadequate glycemic control, defined as HbA1c =7.0% and =11%.
- •4. Stable anti-diabetic treatment regimen.
- •5. Renal impairment: CKD 3A.
- •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 151
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 151
排除标准
- •1. Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
- •2. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
- •3. Severe uncontrolled hypertension defined as SBP =180 mmHg and/or Diastolic Blood Pressure (DBP) =110 mmHg.
- •4. Any of the following Cardiovascular (CV)/Vascular Diseases within 3 months of prior to signing the consent at visit 1:Myocardial infarction, Cardiac surgery or revascularization (CABG/PTCA), Unstable angina, Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously undiagnosed arrhythmia.
- •5. History of any biopsy or imaging verifying intercurrent kidney disease (such as glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.
- •6. Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency.
- •7. Ongoing treatment with any SGLT2-inhibitor or GLP-1 analogue at screening.
- •8. Participation in another clinical study with an Investigational Product (IP) during the last 30 days prior to signing the consent at visit 1.
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