EUCTR2014-000157-37-NL进行中（未招募）不适用
A study to assess the anti-albuminuric effects and variability in response to dapagliflozin in subjects with type 2 diabetes - Effect of dapagliflozin on albuminuria
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Age =18 and =75 years
- •Diagnosis of type 2 diabetes mellitus
- •HbA1c = 6.6% and <11.0%
- •Urinary albumin excretion > 100 mg/g
- •On a stable dose of an ACEi or ARB for at least 4 weeks prior to randomization
- •On a stable dose of blood glucose lowering medication for at least 4 weeks prior to randomization
- •eGFR = 45 mL/min/1.73m2
- •Willing to sign informed consent
- •Women of Child-Bearing Potential (WOCBP):
- •oWOCBP must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized.
- •oWOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of HCG) within 0 to 72 hours before the first dose of study drug.
- •oWomen must not be breast-feeding.
- •WOCBP comprises women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal (see definition below). The following women are WOCBP:
- •oWomen using the following methods to prevent pregnancy: Oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as intrauterine devices or barrier methods (diaphragm, condoms, spermicides).
- •oWomen who are practicing abstinence.
- •oWomen who have a partner who is sterile (eg, due to vasectomy).
- •Post-menopause is defined as:
- •oWomen who have had amenorrhea for ? 12 consecutive months (without another cause) and who have a documented serum follicle-stimulating hormone (FSH) level > 35 mIU/mL.
- •oWomen who have irregular menstrual periods and a documented serum FSH level > 35 mIU/mL.
- •oWomen who are taking hormone replacement therapy (HRT).
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •Type 1 diabetes
- •Urinary albumin excretion > 3500 mg/day
- •Active malignancy
- •Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
- •oHistory of active inflammatory bowel disease within the last six months;
- •oMajor gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
- •oGastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
- •oPancreatic injury or pancreatitis within the last six months;
- •oEvidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at inclusion visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt;
- •oEvidence of urinary obstruction of difficulty in voiding at screening
- •History of severe hypersensitivity or contraindications to dapagliflozin
- •Subject who, in the assessment of the investigator, may be at risk for dehydration or volume depletion that may affect the interpretation of efficacy or safety data
- •Participation in any clinical investigation within 3 months prior to initial dosing.
- •Donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing.
- •History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
- •History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- •Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- •Pregnancy or breastfeeding
- •WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug.
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