Influence of insulin therapy in non-diabetic patients admitted to hospital with acute exacerbations of chronic obstructive pulmonary disease (COPD) - insulin in COPD
Phase 1
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
- Registration Number
- EUCTR2007-000666-20-GB
- Lead Sponsor
- Royal Bournemouth Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 371
Inclusion Criteria
Patients who are NOT diabetic, admitted with COPD who are likely to be prescribed corticosteroids as part of usual care with an admission glucose level (before steroids) between 6.1 and 11.1 mmol/l.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patients with diabetes mellitus
Patients who are nil by mouth.
Patients with severe co-morbid disease with an anticipated life expectancy of < 6 months.
Patients who are unable to provide informed consent.
Age <18 years.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if the effect of treating hyperglycaemia in patients admitted to hospital with an acute exacerbation of chronic obstructive pulmonary disease can reduce their readmission rate to hospital. ;Secondary Objective: Does the use of insulin in COPD exacerbations reduce in-patient length of stay and mortality?;Primary end point(s): The primary end-point of interest will be rate of readmission to hospital within 90 days.
- Secondary Outcome Measures
Name Time Method