EUCTR2017-003820-58-FI进行中（未招募）1 期
A double-blind, randomized, parallel group, phase IV study to investigate the effects of DAPAgliflozin on CARDiac substrate uptake, myocardial efficiency and myocardial contractile work in type 2 diabetes patients. - DAPACARD
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
- 52
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
入选标准
- •- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
- •- Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
- •- Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of =42 mmol/mol (6.0%) and =75 mmol/mol (9.0%) measured at local hospital laboratory.
- •- Females or males =40 years up to 75 years of age.
- •- No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.
- •- Normal left ventricular ejection fraction (=50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.
- •- Body mass index (BMI) = 25 kg/m2.
- •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 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Blood pressure at screening that would require a change in blood pressure treatment over
- •the study period or any of the following: systolic blood pressure >160 mmHg or diastolic
- •blood pressure >100 mmHg.
- •- History of stroke or other clinically significant cerebrovascular disease.
- •- Planned cardiac surgery or angioplasty within 3 months from enrolment.
- •- Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment:
- •a.Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function
- •b.Unstable heart failure or any heart failure with NYHA class III and IV
- •c.Significant valvular disease
- •d.Significant peripheral artery disease
- •- Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.
- •- Patients with severe hepatic impairment (Child-Pugh class C).
- •- Unstable or rapidly progressing renal disease.
- •- Ongoing treatment with other antidiabetic drugs than metformin.
- •- Ongoing treatment with loop diuretics.
- •- Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.
- •- Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2,
- •- Women who has a positive pregnancy test at enrolment or randomization, or are
- •breastfeeding.
- •- Any condition when MRI and CT-PET is contraindicated such as, but not limited to,
- •having a metallic implant (such as pacemaker or cochlear implant), permanent make up,
- •claustrophobia or BMI =40 kg/m2).
- •- Active malignancy requiring treatment at the time of visit 1 (with the exception of
- •successfully treated basal cell or treated squamous cell carcinoma).
- •- Plasma donation within one month of screening or any blood donation/blood loss >450
- •mL during the 3 months prior to screening.
- •- Alcohol or drug abuse within the 3 months prior to informed consent that would interfere
- •with trial participation or any ongoing condition leading to a decreased compliance to
- •study procedures or study treatment intake.
- •- Ongoing treatment with systemic steroids at time of informed consent or change in
- •dosage of thyroid hormones within 6 weeks prior to informed consent or any other
- •uncontrolled endocrine disorder except for T2D.
研究者
相似试验
进行中（未招募）
1 期
A study in type 2 diabetes patients to investigate the effects of DAPAgliflozin on the heart (CARDiac) work, heart nutrient uptake and heart muscle worktype 2 diabetes mellitusEUCTR2017-003820-58-SEAstraZeneca AB52
未知
3 期
Phase III study of MRA-SC 162 mg/weekRheumatoid arthritisJPRN-jRCT2080222455Chugai Pharmaceutical Co., Ltd.50
进行中（未招募）
1 期
A clinical trial to compare the efficacy, safety, and immunogenicity of TX05 with Herceptin® in subjects with HER2 positive early breast cancerEUCTR2017-004190-13-HUTanvex Biologics Corp.800
招募中
不适用
A randomized, double-blind, parallel group, Phase III trial to compare the efficacy, safety, and immunogenicity of TX05 with Herceptin® in subjects with HER2 positive early breast cancer-C50 Malignant neoplasm of breastMalignant neoplasm of breastC50PER-027-18Tanvex Biologics Corporation,88
已完成
3 期
A clinical study to compare the efficacy, safety and immunogencity of two formulations of trastuzumab in women with HER2 Positive Early breast cancer.CTRI/2019/01/017029Tanvex Biologics Corp