Insulin Therapy in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

NCT ID: NCT00467636

Last Updated: 2009-10-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-05-31

Brief Summary

The purpose of this study is to determine the effect of preventing hyperglycaemia in patients admitted to hospital with acute exacerbations of chronic pulmonary disease.

Detailed Description

Hyperglycaemia is associated with increased morbidity and mortality in patients admitted to hospital with acute critical illness, myocardial infarction and stroke. Moreover patients with hyperglycaemia have a significantly longer hospital stay, higher rates of ICU admission, increased in-hospital mortality and are more likely to require transfer to a nursing home. Recently, interventional studies have linked reversal of hyperglycaemia to better clinical outcomes especially in acute myocardial infarction, cardiac surgery and in critically ill patients.

In England and Wales, it is estimated that the number of people with COPD is approaching 1.5 million. The morbidity and economic costs associated with the condition are extremely high with approximately 10% of all acute medical admissions caused by exacerbations of the underlying condition. As a corollary about 15% of patients with COPD need admission to hospital each year.

Acute hyperglycaemia is common among patients admitted with acute exacerbations of COPD. The reasons for this are likely to be multi-factorial including an association between COPD and increased risk of developing diabetes at least in women, the elderly nature of the two populations and the use of glucocorticoids which markedly increases the risk of hyperglycaemia. Admission hyperglycaemia (>11 mmol/l) also appears to predict increased morbidity for patients with COPD admitted to intensive care.

The trial will be a randomised trial of comparison of usual treatment vs intensive insulin treatment for patients with COPD who may or may not have diabetes. Patients will take part in the trial for the first 5 days during their hospital stay.

Conditions

Chronic Obstructive Pulmonary Disease; Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin Glulisine

Blood glucose monitoring and treatment of hyperglycaemia with insulin. Insulin to be with-held if pre meal blood glucose \< 4 mmol/l.

Group Type: EXPERIMENTAL

Insulin Glulisine

Intervention Type: DRUG

Sub cutaneous injection given twice daily for 3 days. Dosage titrated to body mass index and body weight (BMI \< 30 = 0.1 unit/kg. BMI \> 30 = 0.2 unit/kg)

2

Blood glucose monitoring for comparison with treatment arm (1)

Group Type: ACTIVE_COMPARATOR

Blood glucose monitoring

Intervention Type: PROCEDURE

Regular pre and post meal blood glucose monitoring.

Interventions

Blood glucose monitoring

Regular pre and post meal blood glucose monitoring.

Intervention Type: PROCEDURE

Insulin Glulisine

Sub cutaneous injection given twice daily for 3 days. Dosage titrated to body mass index and body weight (BMI \< 30 = 0.1 unit/kg. BMI \> 30 = 0.2 unit/kg)

Intervention Type: DRUG

Other Intervention Names

Apidra

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

The Royal Bournemouth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Royal Bournemouth Hospital

Principal Investigators

David Kerr, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Bournemouth Hospital NHS Trust

Locations

Royal Bournemouth Hospital

Bournemouth, Dorset, United Kingdom

Countries

United Kingdom

Other Identifiers

COPD1

Identifier Type: -

Identifier Source: org_study_id