EUCTR2016-003719-37-GB进行中（未招募）1 期
StUdies of empaGliflozin and its cArdiovascular, Renal and metabolic effects in patients with Diabetes Mellitus (or prediabetes) and Heart Failure (SUGAR-DM-HF) - SUGAR-DM-HF
HS Greater Glasgow and Clyde0 个研究点目标入组 100 人开始时间: 2018年5月9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
- 100
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
- •Written informed consent
- •Male or female, aged =18 years age
- •Type 2 DM (diet-controlled or on stable treatment) or prediabetes
- •o Stable treatment defined as no change in oral therapy agents or doses for diabetes mellitus and (where applicable) <10% change in average total daily insulin dose over last 6 weeks
- •o HbA1c =97 mmol/mol (11%) (routine available data from medical records, recorded in the last year)
- •o Prediabetes defined as HbA1c 39-47 mmol/mol (5.7-6.4%) at the time of screening (specifically for the prediabetes group, HbA1c will be repeated at the time of screening if there are no recent results within the last 3 months, in order to confirm the diagnosis of prediabetes)
- •Heart failure (as defined by presence of typical signs and symptoms of heart failure with documented reduced ejection fraction (ref SIGN and ESC guidelines)):
- •o NYHA class II-IV
- •o LVEF =40%
- •o On stable doses of ACEI, ARB or ARNI for 4 weeks prior to randomisation unless contraindicated or not tolerated. They should also be taking a beta-blocker at a stable dose for 4 weeks unless contraindicated or not tolerated.
- •Women of childbearing potential must be currently adhering to, or be willing to use, highly effective birth control methods for study treatment duration including:
- •o Combined hormonal contraception (oestrogen and progestogen containing medication) either orally, intravaginally, or transdermally
- •o Progesterone only hormonal contraception either orally, injected, or implanted
- •o Intrauterine device (IUD)
- •o Intrauterine hormone release system (IUS)
- •o Bilateral fallopian tube occlusion
- •o Vasectomised partner
- •o Complete sexual abstinence where this is their preferred and usual lifestyle
- •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, post-menopausal being defined as:
- •o Women who have had amenorrhea for = 12 consecutive months (without another medical cause)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Type 1 DM
- •History of hospital admission with a diagnosis of diabetic ketoacidosis (DKA)
- •Insulin use within 1 year of diagnosis of diabetes
- •History of acute or chronic pancreatitis and on insulin treatment for diabetes or low residual c-peptide (random non-fasting level of <0.2 nmol/l)
- •eGFR <30 ml/min/1.73m2 (derived using CKD EPI) at the time of randomisation (based on latest available result; kidney function tests will be repeated at the time of screening if there are no recent results: (a) within last 6 months in patients with eGFR >60 ml/min/1.73m2; (b) within last 3 months in patients with eGFR 45-60 ml/min/1.73m2; (c) within last 1 month in patients with eGFR 30-44 ml/min/1.73m2)
- •Persistent/permanent atrial fibrillation/flutter (conditions which significantly impede MRI image interpretability)
- •Acute coronary syndrome, stroke or surgery within 1 month (small type 2 MI in the context of acute HF does not apply)
- •BMI >52kg/m2
- •Liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal (ULN) at the time of screening (based on latest available result; liver function tests will be repeated at the time of screening if there are no recent (within last 6 months) results in patients without known liver disease)
- •Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
- •Any condition outside the cardiovascular and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator’s clinical judgement
- •Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma, adjuvant hormonal therapy for breast cancer and hormone therapy for prostate cancer)
- •Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia) which in the opinion of the investigator are clinically significant
- •Treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
- •Any uncontrolled endocrine disorder except Type 2 DM or prediabetes
- •Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
- •Known hypersensitivity to the empagliflozin or excipients
- •Known hypersensitivity to gadolinium
- •Inability to give informed consent
- •SGLT2 inhibitor use (current or previous)
- •Devices or any other contraindication to MRI scans
- •Currently pregnant, planning pregnancy, or currently breastfeeding
- •History of previous lower limb amputation (non-traumatic)
- •Current participation in another interventional medical study or within the last 90 days
- •Anyone who, in the investigators’ opinion, is not suitable to participate in the trial for other reasons.
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