EUCTR2020-004929-23-NL进行中（未招募）1 期
Individual albuminuria lowering response to dapagliflozin in a decentralizedclinical trial in patients with type 2 diabetes mellitus and elevated albuminuria - @Home study
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
- 20
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 years
- •- Diagnosis of type 2 diabetes mellitus
- •- Urinary albumin-to-creatinine ratio >20 mg/g (2.26 mg/mmol)
- •- eGFR >30 ml/min/1.73m2
- •- Willing to sign informed consent
- •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 10
排除标准
- •- Diagnosis of type 1 diabetes
- •- Prior treatment with SGLT2 inhibitor in the four weeks prior to randomization
- •- History of severe hypersensitivity or contraindications to dapagliflozin
- •- Unable to monitor blood pressure / body weight or handle digital technologies
- •- History of non-adherence to medical regimens or unwillingness to comply with the study protocol
- •- Participation in any clinical investigation within 3 months prior to initial dosing
- •- Unstable or rapidly progressing renal disease
- •- Severe hepatic impairment (Child-Pugh class C) (only when it is known, since the Child-Pugh score is usually not determined in general practice)
- •- 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 as decided by the treating physician.
- •oPancreatitis within the last six months.
- •oEvidence of serious hepatic disease as determined by the treating physician.
- •oEvidence of urinary obstruction or difficulty in voiding at screening.
- •- Donation or loss of 400 mL 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
- •- 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.
- •- (Missing information on) current pregnancy or breast feeding / attempting to conceive.
- •- Women of childbearing potential (WOCBP):
- •oWOCBP who are unwilling or unable to use 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 the risk of pregnancy is minimized.
- •oWOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent of HCG) within 0 to 72 hours before the first dose of study drug.
- •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:
- •- Women 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).
- •- Women who are practicing abstinence.
- •- Women who have a partner who is sterile (e.g. due to vasectomy).
- •Post-menopause is defined as:
- •- Women 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.
- •- Women who have irregular menstrual periods and a documented serum FSH level >35 mIU/mL.
- •-Women who are taking hormone replacement therapy (HRT).
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