Status:
UNKNOWN
Basal-bolus Insulin Therapy Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study
Lead Sponsor:
Merete Bechmann Christensen
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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. Inpatie...
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 versu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03244241
Start Date
April 1 2017
End Date
April 1 2018
Last Update
August 9 2017
Active Locations (1)
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1
Hvidovre University Hospital
Hvidovre, Denmark, 2650