EUCTR2014-005174-11-SE进行中（未招募）1 期
A randomized, double-blinded placebo-controlled, paralleled designed, investigator sponsored study of the effect of the GLP-1 receptor agonist liraglutide on beta-cell function in C-peptide positive type 1 diabetic patients. - Liraglutide and beta-cell function in type 1 diabetes
ppsala University Hospital0 个研究点目标入组 50 人开始时间: 2015年8月11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
- •Written informed consent for participation of the study, given before undergoing any study-specific procedures.
- •18-30 years of age (age interval inclusive of both the ends). Both males and females are eligible for the study
- •Clinical diagnose of T1D
- •5 or more years duration of disease
- •HbA1C between 45 and 75 mmol/mol
- •Fasting plasma C-peptide concentration >1.5 pmol/l.
- •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 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Inability to provide informed consent
- •Mental incapacity
- •Unwillingness or language barrier precluding adequate understanding or cooperation
- •Ongoing or planned pregnancy within the next 12 months
- •Inadequate or no use of contraceptives
- •Ongoing breast feeding
- •Known sight-threatening retinopathy
- •Creatinine clearance <60 ml/min
- •Life-threatening cardiovascular disease
- •History of drug/alcohol abuse
- •Known or suspected allergy to trial product or related product
- •Recurrent assisted hypoglycemias
- •Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin
- •Uncontrolled hypertension (180/105 mmHg or above)
- •History of acute or chronic pancreatitis
- •Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
- •Personal history of non-familial medullary thyroid carcinoma.
- •Any condition that the investigator or sponsor feel would interfere with trial participation or evaluation of results
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