EUCTR2017-003296-60-DE进行中（未招募）1 期
Empagliflozin effect on glucose toxicity in type 2 diabetes patients - a randomized, open-label, controlled, parallel group, exploratory study - OXIDISE
niversity Hospital Tuebingen0 个研究点目标入组 50 人开始时间: 2018年1月29日最近更新:
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
- 50
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
- •Male or female patients aged between 40 and 70 years (including) at the first screening visit
- •T2DM patients with HbA1c between 7-9% (including), receiving metformin and/or DPP IV-inhibitor
- •Accepted background medication:
- •Metformin and/or DPP-IV inhibitors
- •Stable treatment with antidiabetic drugs over the last 4 weeks
- •Body mass index (BMI) between 25 kg/m2 and 40 kg/m2 (including)
- •Ability to understand and follow study-related instructions
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Unstable Angina pectoris, myocardial infarction or stroke within 1 year before inclusion in the study
- •History of atrial fibrillation
- •Uncontrolled arterial hypertension (> 160/100 mmHg in three subsequent measurements – mean value)
- •eGFR < 60 ml/min/1.73 m2
- •Marcoalbuminuria defined as albumin > 200 mg/l in spontaneous urine
- •Triglyceride > 250mg/dl
- •Genetic muscle disease
- •Known coagulation disorder
- •Treatment with anti-platelet therapy and anticoagulation which cannot be paused for medical reasons
- •Treatment with anticoagulants within 7 days prior to the muscle biopsy
- •Occurrence of ketoacidosis with the requirement for emergency care
- •Contraindications according to the local SmPC of Lantus® or Jardiance® (see Appendix 1)
- •History of hypersensitivity to any of the study drugs or their ingredients or to drugs with similar structure or to the local anesthetic scandicaine or lidocaine
- •Addiction or other diseases that preclude the patient from appropriately assessing the nature and scope as well as possible consequences of the clinical study
- •Pregnant or breast-feeding women
- •Women of childbearing potential unless women who meet the following criteria:
- •Post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH > 40 U/mL)
- •Postoperatively (six weeks after bilateral ovariectomy with or without hysterectomy)
- •Regular and correct use of a contraceptive method with error rate < 1% per year such as implants, depot injections, oral contraceptives or intrauterine devices
- •Sexual abstinence
- •Vasectomy of the partner
- •Males must agree not to father a child and to refrain from donating semen or sperm while participating in the study and for 90 days following discontinuation from this study
研究者
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