Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia

• Status: Completed
• Trial end date: 2019-02-28
• Target enrollment: 0
• Participant gender: All

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 benefit from optimised insulin treatment, which are patients with type 1 diabetes and high risk of nocturnal severe hypoglycaemia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nordsjaellands Hospital
• Collaborators: Aarhus University Hospital; Copenhagen University Hospital, Denmark; Hvidovre University Hospital; Odense University Hospital; Steno Diabetes Center; Steno Diabetes Center Copenhagen; Sydvestjysk Hospital; Zealand University Hospital
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin Glargine; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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