The effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in subjects with type 1 diabetes and high risk of nocturnal severe hypoglycaemia - HypoDeg

ordsjællands Hospital, Department of Cardiology, Nephrology and Endocrinology0 个研究点目标入组 175 人开始时间: 2014年7月18日最近更新: 2019年11月25日

试验速览

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•Women and men aged 18 years or above
•Type 1 diabetes (WHO criteria) > 5 years
•One or more episodes of nocturnal severe hypoglycaemia during the preceding two years
•Treated with multiple dose insulin injection (> 2) or insulin pump. Both human insulin and insulin analogues are allowed.
•Willingness to a once daily (OD) regimen concerning insulin degludec and insulin glargine
•Willingness to do self-monitoring of blood glucose (SMBG) and keep a diary
•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 175
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•History of primary and secondary adrenal insufficiency, growth hormone deficiency, or untreated myxoedema
•History of unstable angina or major cardiovascular events (myocardial infarction, coronary re-vascularisation, transient ischaemic attack, or stroke within the last three months)
•Heart failure, New York Heart Association (NYHA) class IV
•History of malignancy unless a disease-free period exceeding five years
•History of alcohol or drug abuse
•Treatment with glucose lowering agent(s) other than insulin
•HbA1c > 86 mmol/l (10%)

发起方

ordsjællands Hospital, Department of Cardiology, Nephrology and Endocrinology