Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02192450
• Date of registration: 09/07/2014
• Prospective Registration: Yes
• Primary sponsor: Nordsjaellands Hospital
• Public title: Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia HypoDeg
• Scientific title: The Effect of Insulin Degludec on Risk of Symptomatic Nocturnal Hypoglycaemia in Subjects With Type 1 Diabetes and High Risk of Nocturnal Severe Hypoglycaemia
• Date of first enrolment: January 2015
• Target sample size: 149
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02192450
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Denmark

Contacts

• Name: Ulrik Pedersen-Bjergaard, MD, DMSc
• Affiliation: Nordsjaellands Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Nocturnal Hypoglycemia

Recurrent Severe Hypoglycaemia

Type 1 Diabetes Mellitus

Intervention(s)

Drug: Insulin aspart/degludec

Drug: Insulin aspart/glargine

Primary Outcome(s)

Symptomatic nocturnal hypoglycaemia [Time Frame: 9 months (3-12) of each treatment period]

Secondary Outcome(s)

Change in HbA1c [Time Frame: From baseline to after 12 months of treatment]

Change in glycaemic variability [Time Frame: 4 x overnight stays and 4 x 6 days of CGM]

Any daytime hypoglycaemia (symptomatic, asymptomatic/silent and severe) [Time Frame: 9 months (3-12) of each treatment period]

Quality of life incl. pre-depression scale [Time Frame: At baseline, cross-over and after 24 months]

Severe hypoglycaemia (total, night-time, daytime) [Time Frame: 9 months (3-12) of each treatment period]

Any CGM recorded hypoglycaemia (symptomatic, asymptomatic/silent and severe) [Time Frame: 2 x 6 days in each treatment arm]

Any nocturnal hypoglycaemia (incl. asymptomatic/silent events) [Time Frame: 9 months (3-12) of each treatment period]

Insulin doses [Time Frame: End of each treatment period]

Any in-hospital nocturnal hypoglycaemia (incl. asymptomatic/silent events) [Time Frame: 2 overnight stays in each treatment arm]

Secondary ID(s)

HypoDeg

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Copenhagen University Hospital, Denmark

Steno Diabetes Center Copenhagen

Zealand University Hospital

Hvidovre University Hospital

Aarhus University Hospital

Sydvestjysk Hospital

Odense University Hospital