EUCTR2015-000335-32-DK进行中（未招募）1 期
Effects of dapagliflozin treatment on urinary proteomic patterns in patients with type 2 diabetes - DapKid
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
- 40
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
- •Male or female patients >18 years of age with a diagnosis of type 2 diabetes (WHO criteria).
- •Patients must be on current stable antiglycaemic treatment with oral drugs (OAD) or insulin 4 weeks before start of study drug and throughout study duration.
- •Patients must be on stable antihypertensive treatment (must include renin-angiotensin system blocking treatment) 4 weeks before start of study drug and throughout study duration.
- •HbA1c >7.5 %
- •Urinary albumin creatinine ratio (UACR) > 30 mg/g (in =2 out 3 morning spot urine collections prior to randomisation).
- •eGFR = 45 ml/min/1.73 m2
- •Stable RAAS-blocking treatment (more than or equal to 4 weeks prior to visit 0) If not stable at visit 0, screening phase can be prolonged to 4 weeks.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Current treatment with loop diuretics
- •Current treatment with thiazolidinediones
- •Current treatment with dapagliflozin or other SGLT2 inhibitor
- •Ongoing cancer treatment
- •Patients on hypertension treatment who are is not on stable antihypertensive treatment (must include renin-angiotensin system blocking treatment) 4 weeks before start of study drug and throughout study duration
- •Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
- •Total bilirubin >2.0 mg/dL (34.2 µmol/L)
- •Positive serologic evidence of current infectious liver disease including, Hepatitis B surface antigen and antibody and Hepatitis C virus antibody
- •eGFR: <45 mL/min (calculated by MDRD formula)
- •History of unstable or rapidly progressing renal disease
- •Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status
- •Recent Cardiovascular Events in a patient:
- •1. Acute Coronary Syndrome (ACS) within 2 months prior to enrolment 2.Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment
- •3. Acute Stroke or TIA within two months prior to enrolment
- •4. Less than two months post coronary artery revascularization
- •Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure. Note: eligible patients with congestive heart failure, especially those who are on diuretic therapy, should have careful monitoring of their volume status throughout the study.
- •Pregnant or breastfeeding patients
- •Patients who, in the judgement of the investigator, may be at risk for dehydration
研究者
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