EUCTR2012-002278-30-DE进行中（未招募）不适用
Effects of Linagliptin on Renal Endothelium Function in Patients with Type 2 Diabetes.
niversity Hospital Erlangen0 个研究点开始时间: 2012年6月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Age between 18 and 70 years
- •Type 2 diabetes without diabetic nephropathy (definition see exclusion criteria)
- •Male and Female patients are eligible. Females of child bearing potential or within two years of the menopause are only eligible if pregnancy test at the screening visit is negative and they use adequate contraceptive precautions during the trial.
- •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
- •Patients with more than on one blood glucose lowering medication or on one antidiabetic drug that can not be discontinued for the study period.
- •Use of insulin, glitazone or gliptine within the past 3 months
- •Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 6 months prior to study inclusion
- •Urinary albumin excretion (UACR) > 100 mg/g (early morning spot urine)
- •eGFR <45 ml/min/1.73m² (MDRD Formula)
- •Uncontrolled arterial hypertension (RR =180/ =110mmHg)
- •HbA1c = 10%
- •Fasting plasma glucose = 240 mg/dl
- •Body mass index = 40 kg/m²
- •Triglyceride levels = 1000 mg/dl
- •HDL-cholesterol levels <25 mg/dl
- •Overt congestive heart failure (CHF) or history of CHF
- •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, serum creatinine > 2mg/dl
- •Drug or alcohol abusus
- •Pregnant or breast-feeding patients
- •Any patient currently receiving chronic (>30 consecutive days) treatment with an oral corticosteroid
- •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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