Effect of the GLP-1 receptor agonist exenatide on impaired hypoglycaemic awareness in type 1 diabetes - Exenatide and impaired hypoglycaemic awareness in T1DM

Radboudumc0 个研究点目标入组 15 人开始时间: 2016年9月20日最近更新: 2018年3月26日

适应症

试验速览

暂无简介。

•Type 1 diabetes, disease duration >1 year
•Age >18 years, <70 years
•Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump)
•Impaired hypoglycaemic awareness as assessed by a score of 3 or more on the modified Dutch translation of the Clarke questionnaire
•Glycated haemoglobin (HbA1c) =42 mmol/mol (6%) and =75 mmol/mol (9.0%)
•Ability to provide 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 15
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Treatment with incretin-based therapy (DPP-IV inhibitors or GLP-1RAs)
•Known intolerance to GLP-1RAs (including allergy)
•Treatment with glucose-modefying or immune-modefying agents, e.g. prednisolon
•History of cardiovascular disease or laser coagulation for proliferative retinopathy (past 6 months)
•Proliferative retinopathy
•Symptomatic diabetic neuropathy
•Diabetic nephropathy as reflected by albumin-creatinin ratio >30 mmol/mg or MDRD <60 ml/min/1.73 m2
•Known heart failure
•History of pancreatitis (acute or chronic) or pancreatic cancer
•Body-mass index >40 kg/m2
•Blood pressure >160/90 mmHg
•Use of premixed insulin or of long-acting insulin alone
•Total daily insulin dose requirements <20 units unless on pump treatment
•Pregnancy or unwillingness to undertake measures for birth control

发起方