Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes, inpatient diabetes management, basal-bolus insulin
Brief summary
Hyperglycemia during admission is associated with increased rate of complications and longer hospital stays, thus insulin treatment is recommended for all diabetes patients with hyperglycemia. Inpatient studies of non-critically ill patients show better glycemic control with the use of basal-bolus insulin therapy compared to sliding scale insulin therapy, but increased rates of hypoglycemia. The investigators hypothesize that basal-bolus insulin therapy with a new ultra-long-action basal insulin can treat hyperglycemia more efficiently than sliding scale insulin, with few episodes of hypoglycemia.
Detailed description
The aim of this study is 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. The design of the trial is an open, randomized controlled trial with two parallel arms (treatment arm and control arm). Randomization is 1:1.
Interventions
DRUGInsulin Degludec 100 UNT/ML [Tresiba]
Basal-bolus insulin regime
Sponsors
Novo Nordisk A/S
Merete Bechmann Christensen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
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 (\>40 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in mean daily plasma glucose between the two groups | Duration of hospital stay, an expected average of 8 days | Difference in mean daily plasma glucose between the two groups, calculated by using the four daily pre-meal and bedside PG values per patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time spent in glycemic range | Duration of hospital stay, an expected average of 8 days | Based on bedside PG measures and on CGM data |
| Time spent in hyperglycemic range | Duration of hospital stay, an expected average of 8 days | Based on bedside PG measures and on CGM data |
| Length of hospital stay | Duration of hospital stay, an expected average of 8 days | Mean duration of hospital stay |
| Mean number and rates of hypoglycemic events (PG ≤ 3.9 mmol/L) | Duration of hospital stay, an expected average of 8 days | Based on bedside PG measures and on CGM data |
| Number of hospital acquired infections during admission | Duration of hospital stay, an expected average of 8 days | Data from hospital record |
| Number of post-discharge infections or re-admissions 1 month after discharge | 1 month | Data collected on follow-up 1 month after discharge |
| Difference in insulin dose between groups | Duration of hospital stay, an expected average of 8 days | Calculated as mean insulin dose during admission |
Countries
Denmark
Contacts
Primary ContactMerete B Christensen, MD
Backup ContactKirsten Norgaard, DMSC
Outcome results
None listed