NL-OMON50915已完成不适用
Individual albuminuria lowering response to dapagliflozin in a decentralized clinical trial in patients with type 2 diabetes mellitus and elevated albuminuria - @Home study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
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
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
- •- Unstable or rapidly progressing renal disease
- •- Severe hepatic impairment (Child-Pugh class C) as determined by the treating
- •- 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:
- •o History of active inflammatory bowel disease, within the last six months.
- •o Major gastrointestinal tract surgery as decided by the treating physician
- •o Pancreatitis within the last six months.
- •o Evidence of serious hepatic disease as determined by the treating physician
- •o Evidence of urinary obstruction or difficulty in voiding at screening.
- •- Confirmed lactose intolerance demonstrated with a lactose intolerance test.
- •- 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.
- •- Current pregnancy or breast feeding / attempting to conceive.
- •- Women of childbearing potential (WOCBP):
- •o WOCBP 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
- •o WOCBP 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
- 另有 2 项未显示
研究者
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