EUCTR2014-003053-34-DE进行中（未招募）不适用
Randomized, double-blind, placebo controlled, crossover clinical study to analyse the effect of empagliflozin on microvascular circulation - Impact of Empagliflozin on microvascular circulation
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Type 2 diabetes mellitus defined by fasting glucose = 126 mg/dl or HbA1c = 6.5% or on blood glucose lowering medication
- •Age of 18 - 75 years
- •Male and Female patients (females of child bearing potential must be using adequate contraceptive precautions)
- •Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit
- •Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any other form of diabetes mellitus than type 2 diabetes mellitus
- •Use of insulin, glitazone, gliptine or SGLT-2 inhibitor within the past 3 months
- •Patients with more than one oral blood glucose lowering medication
- •Any other oral antidiabetic drug that cannot be discontinued for the study period
- •HbA1c = 10%
- •Fasting plasma glucose > 240 mg/dl
- •Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 6 months prior to study inclusion
- •UACR = 300 mg/g (early morning spot urine)
- •eGFR < 60 ml/min/1.73m²
- •Uncontrolled arterial hypertension (RR = 180/110 mmHg)
- •Congestive heart failure (CHF) NYHA stage III and IV
- •Severe disorders of the gastrointestinal tract or other diseases which interfere the pharmacodynamics and pharmakinetics of study drugs
- •Significant laboratory abnormalities such as SGOT or SGPT levels more than 3 x above the upper limit of normal range
- •Drug or alcohol abusus
- •Pregnant or breast-feeding patients
- •Use of loop diuretics
- •History of repetitive urogenital infection per year
- •Body mass index > 40 kg/m²
- •Triglyceride levels > 1000 mg/dl
- •HDL-cholesterol levels < 25 mg/dl
- •Any patient currently receiving chronic (>30 consecutive days) treatment with an oral corticosteroid
- •History of epilepsia or history of seizures
- •Patients being treated for severe auto immune disease e.g. lupus
- •Participation in another clinical study within 30 days prior to visit 1
- •Individuals at risk for poor protocol or medication compliance
- •Subject who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V
研究者
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