EUCTR2015-005288-17-GR进行中（未招募）1 期
A study of the effects of dapagliflozin on ambulatory aortic pressure, arterial stiffness and urine albumin excretion in patients with type 2 diabetes. - DAPA
???????? ???????? ???????S ????????S?S (Hellenic Society of Medical Education)0 个研究点目标入组 160 人开始时间: 2016年3月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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.Age >18 and <70 years old
- •2.Type 2 diabetes mellitus
- •3.Glycated hemoglobin >7% and <9%
- •4.Patients on stable dose of metformin of at least 1500 mg for the past 3 months.
- •5.Patient to provide 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Hypovolemic patients.
- •2.Patients on loop diuretics.
- •3.Patients with low BP (office SBP <110 mmHg) or orthostatic hypotension (BP drop >20 mmHg and SBP <110 mmHg in standing position at 1 min).
- •4.Patients on antidiabetic drugs other than metformin.
- •5.Secondary hypertension.
- •6.Stage 2 hypertension or higher (office SBP =160 mmHg or DBP =100 mmHg).
- •7.Chronic kidney disease stage 3 or higher (GFR<60 mL/min/1.73 m2).
- •8.Myocardial infarction or unstable angina episode within the past 3 months, or congestive heart failure class III-IV according to New York Heart Association criteria.
- •9.Pregnancy or childbearing potential [defined as women which have entered menses and are not post-menopausal (menopause is defined as the absence of menses for at least 12 months without any other medical cause in women of typical age) or women that have been subjected to permanent sterilization (ie. tubal ligation, hysterectomy, bilateral oophorectomy or bilateral salpingectomy)].
- •10.History of liver disease or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN or total bilirubin >2.0 mg/dL.
- •11.History of malignancy of any organ system (resected basal cell carcinoma considered cured is exempted) within the past 5 years prior to Visit 1 (V1).
- •12.History of drug or alcohol abuse within the last one year.
- •13.Any contraindication or history of hypersensitivity to the study drug or to drugs with similar chemical structures.
- •14.Any other surgical or medical condition that, in the opinion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.
- •15.Intake of an investigational drug in another trial within 30 days prior to Visit 1 (V1).
研究者
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