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Insulin Therapy in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

Primary Purpose

Chronic Obstructive Pulmonary Disease, Hyperglycemia

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Blood glucose monitoring
Insulin Glulisine
Sponsored by
The Royal Bournemouth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Corticosteroid induced hyperglycaemia, Insulin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Bournemouth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin Glulisine

2

Arm Description

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

Blood glucose monitoring for comparison with treatment arm (1)

Outcomes

Primary Outcome Measures

Rate of re-admission to hospital within 90 days.

Secondary Outcome Measures

Length of stay
In-patient mortality
Spirometry at baseline, day 3 and prior to discharge
Achieved glucose levels
Hypoglycaemic events (<4 mmol/l with or without symptoms)
Frequency of positive sputum cultures
Change in CRP and IL-6 levels between baseline and day 5

Full Information

First Posted
April 27, 2007
Last Updated
October 1, 2009
Sponsor
The Royal Bournemouth Hospital
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00467636
Brief Title
Insulin Therapy in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Official Title
Influence of Insulin Therapy in Patients Admitted to Hospital With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Terminated
Why Stopped
Difficulty recruiting (early discharge scheme initiated)
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Royal Bournemouth Hospital
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Hyperglycemia
Keywords
Chronic Obstructive Pulmonary Disease, Corticosteroid induced hyperglycaemia, Insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin Glulisine
Arm Type
Experimental
Arm Description
Blood glucose monitoring and treatment of hyperglycaemia with insulin. Insulin to be with-held if pre meal blood glucose < 4 mmol/l.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Blood glucose monitoring for comparison with treatment arm (1)
Intervention Type
Procedure
Intervention Name(s)
Blood glucose monitoring
Intervention Description
Regular pre and post meal blood glucose monitoring.
Intervention Type
Drug
Intervention Name(s)
Insulin Glulisine
Other Intervention Name(s)
Apidra
Intervention Description
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)
Primary Outcome Measure Information:
Title
Rate of re-admission to hospital within 90 days.
Time Frame
90 days after discharged from hospital
Secondary Outcome Measure Information:
Title
Length of stay
Time Frame
oct 2009
Title
In-patient mortality
Time Frame
look at cause death. for statistical purpose oct 2009
Title
Spirometry at baseline, day 3 and prior to discharge
Time Frame
oct 2009
Title
Achieved glucose levels
Time Frame
oct 2009
Title
Hypoglycaemic events (<4 mmol/l with or without symptoms)
Time Frame
instigate hypoglycaemia protocol at time. for statistical purpose oct 2009.
Title
Frequency of positive sputum cultures
Time Frame
oct 2009
Title
Change in CRP and IL-6 levels between baseline and day 5
Time Frame
oct 2009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kerr, MD
Organizational Affiliation
Royal Bournemouth Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom

12. IPD Sharing Statement

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Insulin Therapy in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

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