Chronic Obstructive Pulmonary DiseaseNCT00467636
Insulin Therapy in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
A study testing Blood glucose monitoring and Insulin Glulisine in people with Chronic Obstructive Pulmonary Disease and Hyperglycemia, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Hyperglycemia
- What is being tested?
- Blood glucose monitoring and Insulin Glulisine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2007to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW
About this study
Official title: 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.
Read the 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.
- Being tested
- Blood glucose monitoring, Insulin Glulisine
- Keywords
- Chronic Obstructive Pulmonary Disease, Corticosteroid induced hyperglycaemia, Insulin
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood glucose monitoringProcedure or surgery
Regular pre and post meal blood glucose monitoring.
Insulin GlulisineDrug
Also called Apidra
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)
| Study group | Role | What they receive |
|---|---|---|
| Insulin Glulisine | Experimental | Blood glucose monitoring and treatment of hyperglycaemia with insulin. Insulin to be with-held if pre meal blood glucose < 4 mmol/l. Receives: Drug: Insulin Glulisine |
| 2 | Active comparator | Blood glucose monitoring for comparison with treatment arm (1) Receives: Procedure: Blood glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of re-admission to hospital within 90 days.
Measured: 90 days after discharged from hospital
Secondary outcomes (7)
Length of stay
Measured: oct 2009
In-patient mortality
Measured: look at cause death. for statistical purpose oct 2009
Spirometry at baseline, day 3 and prior to discharge
Measured: oct 2009
Achieved glucose levels
Measured: oct 2009
Hypoglycaemic events (<4 mmol/l with or without symptoms)
Measured: instigate hypoglycaemia protocol at time. for statistical purpose oct 2009.
Frequency of positive sputum cultures
Measured: oct 2009
Change in CRP and IL-6 levels between baseline and day 5
Measured: oct 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Difficulty recruiting (early discharge scheme initiated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Bournemouth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- David Kerr, MD, Principal investigator, Royal Bournemouth Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467636
- Sponsor's protocol ID
- COPD1
- Status last verified
- Oct 2009
- First submitted
- 27 Apr 2007
- Last updated
- 2 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Insulin Therapy in Patients Admitted to Hospital With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00467636
- Acronym / sponsor ID
- COPD1
- Keywords
- Chronic Obstructive Pulmonary Disease, Corticosteroid induced hyperglycaemia, Insulin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting (early discharge scheme initiated)
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The Royal Bournemouth HospitalUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jul 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 30 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Glulisine | Experimental | Drug: Insulin GlulisineBlood glucose monitoring and treatment of hyperglycaemia with insulin. Insulin to be with-held if pre meal blood glucose < 4 mmol/l. |
| 2 | Active comparator | Procedure: Blood glucose monitoringBlood glucose monitoring for comparison with treatment arm (1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood glucose monitoringRegular pre and post meal blood glucose monitoring. | Procedure or surgery | 2 |
| Insulin GlulisineAlso: ApidraSub 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) | Drug | Insulin Glulisine |
Primary outcome
Rate of re-admission to hospital within 90 days.
Time frame: 90 days after discharged from hospital
7 secondary outcomes
Length of stay
Time frame: oct 2009
In-patient mortality
Time frame: look at cause death. for statistical purpose oct 2009
Spirometry at baseline, day 3 and prior to discharge
Time frame: oct 2009
Achieved glucose levels
Time frame: oct 2009
Hypoglycaemic events (<4 mmol/l with or without symptoms)
Time frame: instigate hypoglycaemia protocol at time. for statistical purpose oct 2009.
Frequency of positive sputum cultures
Time frame: oct 2009
Change in CRP and IL-6 levels between baseline and day 5
Time frame: oct 2009
Results and safety
The study was stopped early (reason given: Difficulty recruiting (early discharge scheme initiated)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kerr, MD principal investigator
Royal Bournemouth Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood glucose monitoring and Insulin Glulisine in people with Chronic Obstructive Pulmonary Disease and Hyperglycemia, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty recruiting (early discharge scheme initiated)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of re-admission to hospital within 90 days. (time frame: 90 days after discharged from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2009; AzTrials last refreshed its copy on 3 Nov 2026.