NL-OMON49588已完成4 期
DAPASALT: An Open Label, Phase IV, Mechanistic, Three-Arm Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin treatment in Type 2 Diabetes Mellitus Patients with Either Preserved or Impaired Renal Function and Non-Diabetics with Impaired Renal Function - DAPASALT
Astra Zeneca0 个研究点目标入组 45 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Based on Protocol amendment 5.0, 1. In the diabetic arms - a diagnosis of T2DM
- •with glycosylated haemoglobin (HbA1c) >=6.5% (>=48 mmol/mol)
- •and <10% (<86 mmol/mol); and eGFR (CKD-EPI) between >=25 and <=50 mL/min/1.73m2
- •or between >90 and <=130 mL/min/1.73m2 for patients aged 59 or younger, between
- •>85 and <=130 mL/min/1.73m2 for patients aged 60 to 69, and between >75 and <=130
- •mL/min/1.73m2 for patients aged 70 or older at the Screening Visit (Visit 1).,
- •2. In the non-diabetic arms, HbA1c <6.5% (<48 mmol/mol) and an eGFR (CKD-EPI)
- •between >=25 and <=50 mL/min/1.73m2 at the Screening Visit (Visit 1)., 3. Patient
- •specific optimal antihypertensive dose of an angiotensin receptor blocker (ARB)
- •(as per Investigator*s judgement) for at least 6 weeks prior to Visit 4 (Day
- •1)., 4. In the diabetic arm (Group 2) an appropriate stable dose of metformin,
- •or sulphonylurea, or metformin+sulphonylurea as anti-diabetic therapy for the
- •last 12 weeks prior to (Visit 4, Day 1)., 5. In the diabetic arm with impaired
- •renal function (Group 1) a stable insulin dosing (intermediate, long*acting,
- •premixed insulin, basal bolus insulin) for the last 12 weeks prior to Visit 4
- •(Day 1) as judged by the Investigator. Metformin or sulphonylurea, or
- •metformin+sulphonylurea together with insulin would be accepted, but is not
- •mandatory. If used, stable dose of metformin or sulphonylurea, or
- •metformin+sulphonylurea as anti-diabetic therapy for the last 12 weeks prior to
- •Visit 4 (Day 1) is required., 6. Stable urinary sodium excretion on 2
- •successive 24-hr urinary sodium excretion measurements (<20% difference between
- •Days *3 and *2)., For an extensive description of the inclusion criteria, see
- •Protocol paragraph 4.1
排除标准
- •Study-related:
- •1. Previous enrolment in the present study or participation in another clinical
- •study with an investigational product during the last 6 months prior to
- •Screening Visit (Visit 1, Day *28 until day -8).
- •2. Involvement in the planning and conduct of the study (applies to both
- •AstraZeneca staff and staff at third party vendor or at the investigational
- •3. Hypersensitivity to dapagliflozin, indocyanine green, sodium iodide, or
- •iodine, or patients who have poorly tolerated indocyanine green in the past.
- •4. Pacemaker or other implanted electronic devices.
- •5. Pregnancy.
- •6. Breastfeeding., General health-related:
- •7. Known clinically significant disease or disorder; or clinically relevant
- •abnormal findings in physical examination, clinical chemistry, haematology, and
- •urinalysis; or unstable or rapidly progressing renal disease; or any other
- •condition or minor medical complaint, which, in the opinion of the
- •Investigator, may either put the patient at risk because of participation in
- •the study, or influence the results, or the patient*s ability to participate in
- •the study and comply with study procedures, restrictions and requirements.
- •8. Diagnosis of T1DM.
- •9. Hyperthyroidism or autonomic thyroid adenomas.
- •10. Abnormal vital signs, after 10 minutes supine rest, defined as any of the
- •following (Visit 1):
- •- Systolic blood pressure above 180 mmHg.
- •- Diastolic blood pressure above 110 mmHg.
- •- Pulse <50 bpm or >100 bpm
- •11. Any of the following cardiovascular/vascular diseases within 3 months prior
- •to signing the consent at Visit 1, as assessed by the Investigator: myocardial
- •infarction, cardiac surgery or revascularization (coronary artery bypass graft
- •[CABG]/ percutaneous transluminal coronary angioplasty [PTCA]), unstable
- •angina, unstable heart failure, heart failure New York Heart Association Class
- •IV, transient ischemic attack or significant cerebrovascular disease, unstable
- •or previously undiagnosed arrhythmia.
- •12. Patients with severe hepatic impairment (Child-Pugh C).
- •13. Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents,
- •unless the diet or treatment has been stopped at least 3 months before
- •Screening Visit, ensuring patients having a stable body weight with no verified
- •body weight variability of >3 kg during the 3 months before Screening Visit.,
- •Renal failure-related:
- •14. Symptoms/complaints suggestive of established neurogenic bladder and/or
- •incomplete bladder emptying.
- •15. History of bladder cancer.
- •16. Diagnosis of polycystic kidney disease.
- •17. History of or current lupus nephritis.
- •18. Urinary albumin excretion >1000 mg/g per day at the Screening Visit based
- •on spot urine sample (quantitative assessment)., for further details, see
- •Protocol v5.0 paragraph 4.2.1
研究者
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