Insulin Therapy in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

Influence of Insulin Therapy in Patients Admitted to Hospital With Acute Exacerbations of Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Terminated
• Conditions: Hyperglycemia; Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Insulin Glulisine; Procedure: Blood glucose monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • Royal Bournemouth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin Glulisine; Blood glucose monitoring and treatment of hyperglycaemia with insulin. Insulin to be with-held if pre meal blood glucose < 4 mmol/l.	Drug: 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); Other Names: Apidra
Active Comparator: 2; Blood glucose monitoring for comparison with treatment arm (1)	Procedure: Blood glucose monitoring; Regular pre and post meal blood glucose monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of re-admission to hospital within 90 days.	90 days after discharged from hospital

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of stay	oct 2009
In-patient mortality	look at cause death. for statistical purpose oct 2009
Spirometry at baseline, day 3 and prior to discharge	oct 2009
Achieved glucose levels	oct 2009
Hypoglycaemic events (<4 mmol/l with or without symptoms)	instigate hypoglycaemia protocol at time. for statistical purpose oct 2009.
Frequency of positive sputum cultures	oct 2009
Change in CRP and IL-6 levels between baseline and day 5	oct 2009

Collaborators and Investigators

• Sponsor: The Royal Bournemouth Hospital
• Collaborators: Sanofi
• Investigators: Principal Investigator: David Kerr, MD, Royal Bournemouth Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: April 27, 2007
• First Submitted That Met QC Criteria: April 27, 2007
• First Posted (Estimate): April 30, 2007

Study Record Updates

• Last Update Posted (Estimate): October 2, 2009
• Last Update Submitted That Met QC Criteria: October 1, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Insulin; Chronic Obstructive Pulmonary Disease; Corticosteroid induced hyperglycaemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Respiratory Tract Diseases; Hyperglycemia; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin glulisine
• Other Study ID Numbers: COPD1 (Deutsche Lungenstiftung)