EUCTR2010-023107-10-DE进行中（未招募）不适用
The influence of liraglutide on hypoglycaemia counterregulation and pulsatile insulin secretion in type 2 diabetics
St. Josef-Hospital, Ruhr University, Bochum0 个研究点开始时间: 2012年6月29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 (at least 6 months) based on the disease diagnostic criteria WHO) classification
- •In case of existing therapy with sulfonlyurea or DPP 4–inhibitors agreement to pause the medication 4 weeks before visit 3 takes place and during the study.
- •Men or women from 18 to 70 years, inclusive
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Any contraindications, known allergy / hypersensitivity to liraglutide or another GLP-1 analogue or excipients contained in these products.
- •Participation in an interventional medical, surgical or pharmaceutical study within the last three months prior to entry into the study
- •Any other condition that may preclude the patient from following and completing the protocol
- •Patients with type 1 diabetes mellitus
- •Women of child-bearing age, who are pregnant, plan a pregnancy or do not use a sufficient method of contraception (sterilisation, intrauterine hormone application, oral contraceptives, sexual abstinence or vasectomised partners).
- •Any evidence that the patient will probably not comply with the trial protocol (e.g. lack of willingness to cooperate)
- •Pharmacotherapy with digoxin, lisinopril, warfarin, insulin, GLP-1 analogues
- •Patients with moderate and severe renal impairment (creatinine clearance < 59 ml/min)
- •Impaired liver function (GOT and/or GPT 3x ULN)
- •History of benign/malign thyroid tumours
- •History of chronic pancreatitis/idiopathic acute pancreatitis
- •Cardiac insufficiency NYHA stage I – IV
- •Manifest CHD; history of myocardial infarction
- •Chronic inflammatory enteropathy
- •Diabetic gastroparesis
- •Patients with known haemoglobinopathy or chronic anaemia (Hb < 10 mg/dl)
- •Patients on systemic glucocorticoid treatment (except topic or inhalative preparations) within the last 3 months prior to screening
- •History of thrombosis/embolism, coagulation disorders
- •Alcohol abuse
- •Oncologic disease (except basal cell Ca and squamous cell carcinoma of the skin)
研究者
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