EUCTR2010-018979-16-DE进行中（未招募）不适用
EFFECTS OF SAXAGLITPIN ON ENDOTHELIAL FUNCTION IN PATIENTS WITH TYPE 2 DIABETES - ESENDI
niversity Hospital Erlangen0 个研究点开始时间: 2010年5月3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
- •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 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. Adequate contraceptive precautions include precaution with a Pearl-Index <1 (oral contraceptive pill, subdermal contraceptive rod - Implanon®, intra-uterine spiral, tubular sterilization).
- •The patient must demonstrate that she/he is able and willing to perform blood glucose measurements as necessary for Home Blood Glucose Monitoring by herself/himself after it was demonstrated to her/him.
- •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 insulin therapy
- •Last measured HbA1c = 10%
- •Fasting plasma glucose > 240 mg/dl
- •Blood pressure levels =180/110 mmHg
- •Body mass index >50 kg/m²
- •Triglyceride levels > 500 mg/dl
- •HDL-cholesterol levels <25 mg/dl
- •Estimated creatinine clearance < 50 ml/min/1.73m²
- •Macroalbuminuria defined by urinary albumine-to-creatinine ratio > 300 mg/g
- •Known liver function test >3 times upper limit of normal
- •Pregnant or breast-feeding patients
- •Current or previous (within 6 months) treatment with an incretin-based therapy such as DPP 4 inhibitors and/or GLP-1 mimetics
- •Patients with a history of a hypersensitivity reaction or anaphylaxia in response to a previous treatment to a DPP 4 inhibitor and/or GLP-1 mimetics
- •Any patient currently receiving chronic (>30 consecutive days) treatment with an oral steroid)
- •Acute cardiovascular event (including myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, stroke, TIA. PRIND, intracerebral bleeding) <6 months prior to screening visit (visit 1)
- •Diabetic retinopathy
- •History of epilepsia or history of seizures
- •Patients being treated for severe auto immune disease such as lupus
- •Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and BMS or representative staff and/or staff at the study site)
- •Previous randomisation in the present study
- •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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