Type 2 diabetes MedDRA version: 19.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Tresiba
Product Name: Insulin degludec
Pharmaceutical Form: Suspension for injection in pre-filled pen
INN or Proposed INN: INSULIN DEGLUDEC
CAS Number: 844439-96-9
Concentration unit: U/m
Sponsors
Hvidovre University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • History of type 2 diabetes for at least 6 months • Age 18 – 90 years • Pre-meal plasma glucose in the range 10 – 22,2 mmol/L prior to inclusion • Expected hospital stay longer than 4 days (after inclusion into the trial) • Signed informed consent 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 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Hyperglycemia without known history of type 2 diabetes • Type 1 diabetes mellitus • Severely impaired renal function (eGFR = 30 mL/min/1,73 m2) • Severe hepatic disease • Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months • Pregnant or lactating women or fertile female patients not using chemical, hormonal or mechanical contraceptives or not in menopause (i.e. must not have had regular menstrual bleeding for at least one year) • Planned treatment during hospital stay with intravenous glucose/ insulin for = 12 hours • Treatment at admission or planned treatment during hospital stay with parenteral nutrition or enteral nutrition (i.e. gastroenteric tube feeding) • Treatment at admission or planned treatment during hospital stay with high dose glucocorticoids (= 25 mg) • History or presence of malignancy (except basal skin cancer) unless a disease-free period exceeding five years • Presence of alcohol or drug abuse • Inability to understand the written information or incapability to provide informed consent • Known or suspected hypersensitivity to trial product(s) or related products. • Other concomitant medical or psychological conditions that according to the investigator´s assessment makes the patient unsuitable for study participation • Previous participation in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate and compare the efficacy and safety of basal-bolus insulin therapy using the insulin analogue, insulin degludec once daily and insulin aspart before meals versus standard therapy with sliding scale insulin in non-critical ill hospitalized patients with type 2 diabetes.;Secondary Objective: Not applicable;Primary end point(s): Difference in mean daily plasma glucose between the two groups, calculated by using the four daily pre-meal and bedside PG values per patient.;Timepoint(s) of evaluation of this end point: End of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mean number and rates of hypoglycemic events (PG = 3.9 mmol/L) per patient during hospital stay, based on bedside PG measures. • Mean number and rates of hypoglycemic events during hospital stay based on Continuous glucose monitor (CGM) data • Number of bedside PG values during hospital stay in o glucose target range (PG 5.0 - 10.0 mmol/L) o hypoglycemic ranges (PG = 3.9 mmol/L and PG = 2.8 mmol/L) o hyperglycemic range (PG > 10.1 mmol/L) • Percentage of time spent in the hypoglycemic range = 3.9 mmol/l and = 2.8 mmol/L during hospital stay (based on CGM data). • Percentage of time spent in the glycemic range between 4.0-8.0 mmol/l and time spent in range 4.0-10 mmol/l during hospital stay (based on CGM data). • Percentage of time spent in the hyperglycemic range above 8.0 mmol/l and above 10.0 mmol/l during hospital stay (based on CGM data). • Length of hospital stay • Difference in insulin dose between groups • Number of hospital acquired infections during admission • Number of post-discharge infections or re-admissions 1 month after discharge ;Timepoint(s) of evaluation of this end point: End of treatment | — |
Countries
Denmark
Contacts
Public ContactDept. of Endocrinology 159
Hvidovre Unversity Hospital
Outcome results
None listed