EUCTR2016-003614-27-IT招募中1 期
Study on the effect of dapagliflozin on myocardial insulin sensitivity and perfusion (DapaHeart) - DAPA HEART
IVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI0 个研究点目标入组 52 人开始时间: 2018年2月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
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
- 性别
- All
入选标准
- •1. Provision of informed consent prior to any study specific procedures
- •2. Female or male subjects aged between 40 and 75 inclusive.
- •? Patients who have been surgically sterilized (hysterectomy or tubal-ligation) at least 12 months prior to screening, or
- •? are postmenopausal having had no regular menstrual bleeding for at least one (1) year prior to screening. Menopause will be confirmed by a plasma follicle stimulating hormone (FSH) level of > 35 IU/mL at screening, or
- •? Women with childbearing potential willing not to start a pregnancy during the course of the study and non-nursing women
- •? Men having relationships with women with childbearing potential willing not to procure a pregnancy during the course of the study;
- •3. Patients with type 2 diabetes
- •4. Patients with established, stable CAD, defined as =30% coronary stenosis in at least one major coronary vessel on invasive coronary angiography (ICA) or computed tomography angiography (CTA) performed within 12 months from screening and no indication to revascularization
- •5. Patients with a clinical indication for 13N-ammonia PET-CT, as established by a cardiologist, nuclear medicine physician or diabetologists
- •6. Patients with a body mass index (BMI) equal or greater than 25 kg/m2 but less than 35 kg/m2 [BMI = Weight (kg) / Height squared (m2)]
- •7. Patients with a HbA1c between 7,5% and 8,5% according to the actual clinical conditions of the patients;
- •8. Patients with a diabetes duration <10 years;
- •9. Patients with stable medical therapy [including other anti-hyperglycemic agents (see Table 1, section 5.2.1 for all therapies allowed, as per current standard treatment); pioglitazone and basal-bolus insulin treatment are excluded, as reported in the exclusion criteria 15] for at least 3 months prior to the screening visit (including stable insulin dose defined as no variation more than 30% in daily insulin dose within the preceding 3 months,. The reference for the initial prescription of the insulin dose starts from the values described in Table 1, section 5.2.1,. and is then titrated on the metabolic assessment done for each patient).
- •10. Patients with Fasting C-peptide > 1 ng/mL (0.33 nmol/L) at Visit 0
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) no
- •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 40
排除标准
- •1. Type 1 diabetes (as assessed by medical history); previous diagnosis of Latent Autoimmune Diabetes of Adults (LADA), and or not fulfilling inclusion criteria #10
- •2. History of diabetic ketoacidosis or hyperosmolar non ketotic coma
- •3. NYHA class III or IV
- •4. Unstable angina
- •5. Previous re-vascularisation (either percutaneous coronary intervention or coronary artery bypass graft)
- •6. Reduced left ventricular ejection fraction (=50%)
- •7. Increased likelihood of developing diabetic ketoacidosis (history of DKA, alcohol consumption, volume depletion dehydration, clinical conditions causing diarrhea, vomit and anorexia)
- •8. Moderate to severe renal impairment (eGFR<60 ml/min/1.73m2 as calculated by the modification of diet in renal disease [MDRD] equation or end-stage renal disease); overt proteinuria, defined as Spot urine Microalbumin/Cr ratio of >300 mg/g at screening (Visit 0)
- •9. Severe liver dysfunction
- •10. Asthma
- •11. Uncontrolled blood pressure
- •12. Symptomatic tachy- or bradyarrhythmias
- •13. Previous acute myocardial infarction
- •14. Contraindications to adenosine: known hypersensitivity to adenosine or to any of the excipients; sick sinus syndrome, second or third degree atrio-ventricular block (except in patients with a functioning artificial pacemaker); chronic obstructive lung disease with evidence of bronchospasm (e.g. asthma bronchiale); long QT syndrome; severe hypotension; decompensated states of heart failure
- •15. Use of pioglitazone; use of loop diuretics; basal-bolus insulin therapy; use of systemic steroids less than 3 days prior to the screening visit (Visit 0)
- •16. Known hypersensitivity to the active substance or to any of the excipients in study drug
- •17. Inability to provide informed consent
- •18. Participation in another clinical study with an investigational product during the previous 30 days
- •19. Patients with history of breast, bladder and prostate cancer
- •20. Patients will undergo to surgical procedures
- •21 Patients with acute urinary tract infection
- •22 Patients with history of intolerance to galactose and lactose
- •23. Severe/uncontrolled medical conditions, causing volume depletion
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