Status:
COMPLETED
Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia
Lead Sponsor:
Nordsjaellands Hospital
Collaborating Sponsors:
Steno Diabetes Center Copenhagen
Hvidovre University Hospital
Conditions:
Type 1 Diabetes Mellitus
Nocturnal Hypoglycemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether insulin degludec compared to insulin glargine can reduce the risk of symptomatic nocturnal hypoglycaemia in subjects with the greatest potential benef...
Detailed Description
Background: Insulin degludec is a novel insulin analogue that may reduce the risk of mild nocturnal hypoglycaemia in type 1 diabetes. Patients with type 1 diabetes and recurrent severe hypoglycaemia (...
Eligibility Criteria
Inclusion
- Type 1 diabetes \> 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
- Signed informed consent
Exclusion
- 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
- Pregnant or lactating women
- Women of childbearing potential who are not using chemical (P-pills or gestagen depots) or mechanical (intra-uterine device) contraception
- Participation in another investigational drug study within the last 3 months
- Inability to understand the informed consent
- HbA1c \> 86 mmol/mol (10%)
- Shifting working hours
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2019
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT02192450
Start Date
January 1 2015
End Date
February 28 2019
Last Update
June 27 2019
Active Locations (1)
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1
Nordsjaellands Hospital
Hilleroed, Denmark, 3400