Same as above
- Conditions
- Sypmtomatic nocturnal hypoglycaemia in subjects with type 1 diabetes and high risk of nocturnal severe hypoglyceamiaMedDRA version: 19.1Level: LLTClassification code 10012594Term: DiabetesSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2014-001942-24-DK
- Lead Sponsor
- ordsjællands Hospital, Department of Cardiology, Nephrology and Endocrinology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 175
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%)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method