Sypmtomatic nocturnal hypoglycaemia in subjects with type 1 diabetes and high risk of nocturnal severe hypoglyceamia MedDRA version: 19.1 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Tresiba 100 units/ml, FlexTouch 3 ml
Pharmaceutical Form: Suspension for injection in pre-filled pen
INN or Proposed INN: INSULIN DEGLUDEC
CAS Number: 844439-96-9
Concentration unit: U/ml
Sponsors
Nordsjællands Hospital, Department of Cardiology, Nephrology and Endocrinology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
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 HbA1c > 86 mmol/l (10%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that insulin degludec, compared to insulin glargine, reduces the risk of symptomatic nocturnal hypoglycaemia in subjects with the greatest potential benefit from optimised insulin treatment - which is patients with type 1 diabetes and high risk of nocturnal severe hypoglycaemia. ;Secondary Objective: To investigate the effect of insulin degludec compared to insulin glargine on: Any hypoglycaemia episode (symptomatic, asymptomatic/silent and severe) analysed according to severity and/or time of day Change in HbA1c from baseline Quality of life incl. pre-depression scale ;Primary end point(s): Rate of symptomatic nocturnal hypoglycaemia confirmed by glucose measurement from 3 to 12 months of treatment. The night is defined from 4 hours after evening bolus insulin administration to actual morning bolus insulin administration.;Timepoint(s) of evaluation of this end point: Endpoints will be assessed during the last 9 month of each treatment arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence of severe hypoglycaemia (total, night-time, daytime) from 3 to 12 month of treatment Any nocturnal hypoglycaemia (incl. asymptomatic/silent events) from 3 to 12 month of tratment Any daytime hypoglycaemia (symptomatic, asymptomatic and severe, seperately and combined) from 3 to 12 months of treatment Any CGM recorded hypoglycaemia (symptomatic, asymptomatic/ silent and severe) recorded by blinded CGM 2 x 6 days in each treatment arm Any in-hospital nocturnal hypoglycaemia (incl. asymptomatic/silent events) recorded by overnight plasma glucose profiles in each treatment arm Change in primary endpoint according to baseline HbA1c will be explored Change in HbA1c from baseline to after 12 months of treatment Change in glycaemic variability during night time and CGM Insulin doses at the end of each treatment period Quality of life incl. pre-depression scale;Timepoint(s) of evaluation of this end point: Endpoints will be assessed during the last 9 month of each treatment arms | — |
Countries
Denmark
Contacts
Public ContactNordsjællands Hospital
Department of Cardiology, Nephrology and Endocrinology
Outcome results
None listed