COPDPhase 2IPS2008NCT00764556
Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards
A Phase 2 study testing Insulin in people with COPD and Hyperglycemia, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
Patients with chronic obstructive pulmonary disease (COPD) are commonly admitted to hospital with exacerbations of their lung disease. A combination of the acute illness and treatment with oral steroids causes a rise in blood sugar. Patients with high blood sugar do worse than those with normal blood sugar. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Hyperglycemia
- What is being tested?
- Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2008to May 2009
- Phase
- Phase 2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician diagnosis of AECOPD as primary cause for admission
- Able to enter study within 24 hours of admission
Who cannot join
- Intensive care unit admission
- Moribund or not for active treatment
- Admission expected to last <48 hours
- Unable or unwilling to give informed consent
- Known Type I diabetes mellitus
- Patients with reduced awareness of hypoglycaemia including reduced Glasgow coma scale or those taking beta blockers
- Patients with renal or hepatic failure at increased risk of hypoglycaemia
Trial locations and contacts
1 site in 1 country.
About this study
Patients with chronic obstructive pulmonary disease (COPD) are commonly admitted to hospital with exacerbations of their lung disease. A combination of the acute illness and treatment with oral steroids causes a rise in blood sugar. Patients with high blood sugar do worse than those with normal blood sugar. The aim of this study is to develop a safe and effective protocol for tight control of blood glucose with insulin on acute medical wards outside the intensive care environment. This will allow us to perform a formal trial to determine whether blood glucose control with insulin reduces death and complications from COPD exacerbations.
- Conditions
- COPD, Hyperglycemia
- Being tested
- Insulin
- Keywords
- Glucose, Insulin, COPD, Exacerbations, Tight glycaemic control, Acute hospital ward
- 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.
InsulinDrug
Intravenous insulin (actrapid) Subcutaneous insulin (aspart, glargine, detemir)
| Study group | Role | What they receive |
|---|---|---|
| Tight glycaemic control | Experimental | Intravenous or subcutaneous insulin to control blood glucose to 4.4-6.5mM Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate
Measured: During trial
Secondary outcomes (7)
The frequency of symptomatic hypoglycaemia (capillary glucose≤3.3mM AND symptoms consistent with hypoglycaemia)
Measured: During trial
The frequency of asymptomatic hypoglycaemia (capillary glucose≤3.3mM without any symptoms consistent with hypoglycaemia).
Measured: During treatment
Mean 24 hour capillary glucose concentrations
Measured: During treatment
Proportion of capillary glucose measurements in target range (4.4-6.5mM)
Measured: During treatment
Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system
Measured: During monitoring
Comparison of rates of detection of hypoglycaemia by capillary and continuous blood glucose monitoring
Measured: During monitoring
Quantification of acceptability of the study intervention to patients
Measured: during study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Investigators
- Emma H Baker, PhD, FRCP, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764556
- Sponsor's protocol ID
- SGH-ClinPharm-1
- Other IDs
- EudraCT 2007-004956-35, Ethics 07/H0715/93
- Acronym
- IPS2008
- Status last verified
- Oct 2009
- First submitted
- 1 Oct 2008
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baker EH, Janaway CH, Philips BJ, Brennan AL, Baines DL, Wood DM, Jones PW. Hyperglycaemia is associated with poor outcomes in patients admitted to hospital with acute exacerbations of chronic obstructive pulmonary disease. Thorax. 2006 Apr;61(4):284-9. doi: 10.1136/thx.2005.051029. Epub 2006 Jan 31.
PubMed 16449265Archer JR, Misra S, Simmgen M, Jones PW, Baker EH. Phase II study of tight glycaemic control in COPD patients with exacerbations admitted to the acute medical unit. BMJ Open. 2011 Jul 23;1(1):e000210. doi: 10.1136/bmjopen-2011-000210.
PubMed 22021788
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards
- ClinicalTrials.gov ID
- NCT00764556
- Acronym / sponsor ID
- IPS2008 / SGH-ClinPharm-1
- Conditions
- COPD, Hyperglycemia
- Keywords
- Glucose, Insulin, COPD, Exacerbations, Tight glycaemic control, Acute hospital ward
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 2 Oct 2008 (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.
Patients with chronic obstructive pulmonary disease (COPD) are commonly admitted to hospital with exacerbations of their lung disease. A combination of the acute illness and treatment with oral steroids causes a rise in blood sugar. Patients with high blood sugar do worse than those with normal blood sugar. The aim of this study is to develop a safe and effective protocol for tight control of blood glucose with insulin on acute medical wards outside the intensive care environment. This will allow us to perform a formal trial to determine whether blood glucose control with insulin reduces death and complications from COPD exacerbations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tight glycaemic control | Experimental | Drug: InsulinIntravenous or subcutaneous insulin to control blood glucose to 4.4-6.5mM |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physician diagnosis of AECOPD as primary cause for admission
- Able to enter study within 24 hours of admission
Key exclusion criteria (7 listed)
- Intensive care unit admission
- Moribund or not for active treatment
- Admission expected to last <48 hours
- Unable or unwilling to give informed consent
- Known Type I diabetes mellitus
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 |
|---|---|---|
| InsulinIntravenous insulin (actrapid) Subcutaneous insulin (aspart, glargine, detemir) | Drug | Tight glycaemic control |
Primary outcome
The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate
Time frame: During trial
7 secondary outcomes
The frequency of symptomatic hypoglycaemia (capillary glucose≤3.3mM AND symptoms consistent with hypoglycaemia)
Time frame: During trial
The frequency of asymptomatic hypoglycaemia (capillary glucose≤3.3mM without any symptoms consistent with hypoglycaemia).
Time frame: During treatment
Mean 24 hour capillary glucose concentrations
Time frame: During treatment
Proportion of capillary glucose measurements in target range (4.4-6.5mM)
Time frame: During treatment
Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system
Time frame: During monitoring
Comparison of rates of detection of hypoglycaemia by capillary and continuous blood glucose monitoring
Time frame: During monitoring
Quantification of acceptability of the study intervention to patients
Time frame: during study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
- Background: PubMed 16449265Baker EH, Janaway CH, Philips BJ, Brennan AL, Baines DL, Wood DM, Jones PW. Hyperglycaemia is associated with poor outcomes in patients admitted to hospital with acute exacerbations of chronic obstructive pulmonary disease. Thorax. 2006 Apr;61(4):284-9. doi: 10.1136/thx.2005.051029. Epub 2006 Jan 31.
- Derived from this study: PubMed 22021788Archer JR, Misra S, Simmgen M, Jones PW, Baker EH. Phase II study of tight glycaemic control in COPD patients with exacerbations admitted to the acute medical unit. BMJ Open. 2011 Jul 23;1(1):e000210. doi: 10.1136/bmjopen-2011-000210.
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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.
Emma H Baker, PhD, FRCP principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Insulin in people with COPD and Hyperglycemia, run by St George's, University of London 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 14 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate (time frame: During trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00764556, which also lists 2 linked publications.
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 14 Oct 2009.