EUCTR2012-005317-39-DK进行中（未招募）1 期
iraglutide in type 1 diabetes - A randomised, double-blind, placebo-controlled, parallel group, multi-centre trial of 242 liraglutide treatment in subjects with newly-diagnosed type 1 diabetes (The NewLira Study) - NewLira
Department of Endocrinology, Hvidovre Hospital0 个研究点目标入组 80 人开始时间: 2013年1月17日最近更新:
适应症
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
- 80
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 1 diabetes according to WHO criteria diagnosed = 6 weeks before visit 0
- •*Age 18 - 40 years – both inclusive
- •*Postprandial C-peptide > 0.2 nmol/l following sustacal meal test
- •*Able to understand the written patient information and to give informed consent
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •*Type 2 diabetes
- •*Body mass index <20 kg/m2 at Visit 0
- •*Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
- •*Pregnant or nursing women
- •*Compromised kidney function (eGFR < 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0
- •*Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal at visit 0
- •*Cancer unless in complete remission for > 5 years
- •*Treatment with oral glucocorticoids, calcineurin inhibitors, or dipeptidyl peptidase 4 (DPP4) inhibitors, or other GLP-1 mimetics which in the Investigator’s opinion could interfere with glucose metabolism
- •*Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 3 months
- •*Inflammatory bowel disease
- •*Calcitonin = 50 ng/l at visit 0
- •*Hypoglycaemia unawareness (unability to register low blood glucose)
- •*Acute or chronic pancreatitis
- •*History of thyroid adenoma or carcinoma
- •*Known or suspected hypersensitivity to trial product or related products
- •*Abuse of alcohol or drugs, or any other co-existing condition that would make patients unsuitable to participate in the study, as deemed by the investigators
- •*Receipt of an investigational drug within 30 days prior to visit 0
- •*Simultaneous participation in any other clinical intervention trial
研究者
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