EUCTR2016-001264-11-DE进行中（未招募）1 期
A phase IV, single-center, randomized, double-blind, placebo-controlled, parallel group study on the effects of empagliflozin on left ventricular diastolic function compared to usual care in individuals with type 2 diabetes - EmDia
niversity Medical Center of the Johannes Gutenberg-University Mainz0 个研究点目标入组 158 人开始时间: 2016年6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
- 158
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
- •Subjects meeting all of the following criteria at visit 0 (screening) will be considered for enrollment to the trial:
- •- Diagnosis of type 2 diabetes mellitus with stable glucose-lowering background therapy and/or dietetic treatment for at least 12 weeks
- •- In subjects without glucose-lowering background therapy: the application of Metformin was considered to be unsuitable due to drug intolerance
- •- HbA1c level of = 6.5 % and =10.0% for subjects on antidiabetic background therapy or HbA1c level of = 6.5 % and =9.0% for drug-naïve subjects with dietetic treatment
- •- Diastolic cardiac dysfunction with E/E’ ratio = 8 (2D-echocardiography)
- •- Age 18 – 84 years
- •- BMI = 45 kg/m² (Body Mass Index) (at visit 0 and/or visit 1)
- •- For women: post-menopausal for more than 12 months without an alternative medical cause can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (serum or urine) is available at visit 1 and they are willing to practice highly effective birth control method during trial according to the recommendations of the Clinical Trial Facilitation Group (1). Signed and dated informed consent of the subject must be available before start of any specific trial procedures which is consistent with ICH-GCP guidelines and local legislation.
- •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 39
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 119
排除标准
- •Subjects presenting at least one of the following criteria at visit 0 (screening) will not be enrolled in the trial:
- •- Pretreatment with empagliflozin or other SGLT2 inhibitor within the last 3 months
- •- Pretreatment with known inducers of UGT enzymes
- •- Uncontrolled hyperglycemia with a glucose level > 240 mg/dl (>13.3 mmol/L) after an overnight fast
- •- Impaired renal function, defined as eGFR < 45 ml/min/1.73 m² of body-surface-area
- •- End-stage renal failure or dialysis
- •- Severe hepatic dysfunction, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN)
- •- Acute urinary tract infection (UTI)
- •- Known acute genital infection (GI)
- •- Symptomatic hypotension
- •- Hematocrit above the upper limit of the reference range
- •- Hypoglycemic tendencies
- •- Severe PAD (Fontaine classification Stage IIb - IV)
- •- Medical history of cancer and/or treatment for cancer within the last 5 years, subjects with basalioma can be included in the study
- •- Medical history of pancreatitis or surgery on pancreas
- •- Known ketoacidosis (in the past)
- •- Acute febrile disease
- •- NYHA classification III – IV
- •- Pregnant and/or nursing women at visit 1 (baseline)
- •- Acute coronary syndrome, stroke or TIA within the last 2 months
- •- Alcohol or drug abuse within the last 3 months that would interfere with trial participation
- •- Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial (at visit 0 (screening) or at visit 1 (baseline))
- •- Medical condition that does not allow enrollment in the trial at visit 1 (baseline)
研究者
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