Condition category
Respiratory
Date applied
01/10/2008
Date assigned
20/11/2008
Last edited
26/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emma Baker

ORCID ID

Contact details

Centre for Clinical Pharmacology
Room 66
Ground Floor Jenner Wing
St George's
University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
+44 (0)20 8725 5383
ebaker@sgul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00764556

Protocol/serial number

SGH-ClinPharm-1

Study information

Scientific title

Phase II study: investigation of the safety and efficacy of a protocol for tight glycaemic control in patients with chronic obstructive pulmonary disease (COPD) exacerbations admitted to an acute medical unit

Acronym

IPS 2008

Study hypothesis

This study will test the safety and feasibility of tight control of blood glucose with insulin in patients with acute exacerbations of COPD outside the intensive care setting in acute medical wards.

Ethics approval

Joint UCL/UCLH Ethics Committee gave approval in early 2008 (ref: 07/H0715/93)

Study design

Prospective, non-randomised, phase II study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD)

Intervention

This is a single arm trial. Patients receive insulin with the aim of controlling blood glucose to a target of 4.4 - 6.5 mM. Insulin is initially intravenous (actrapid), then subcutaneous (glargine or detemir plus aspart). Patients receive insulin throughout hospital admission and is stopped on discharge. Follow up is during hospital stay; there is no follow up after discharge for the study.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The frequency of severe hypoglycaemia - neuroglycopaenic symptoms (other than mild agitation) responsive to administration of carbohydrate. The outcomes are measured/looked for continuously during treatment/hospital stay.

Secondary outcome measures

1. The frequency of symptomatic hypoglycaemia (capillary glucose less than or equal to 3.3 mM and symptoms consistent with hypoglycaemia)
2. The frequency of asymptomatic hypoglycaemia (capillary glucose less than or equal to 3.3 mM without any symptoms consistent with hypoglycaemia)
3. Mean 24 hour capillary glucose concentrations
4. Proportion of capillary glucose measurements in target range (4.4 - 6.5 mM)
5. Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system
6. Comparison of rates of detection of hypoglycaemia by capillary and continuous blood glucose monitoring
7. Quantification of acceptability of the study intervention to patients

The outcomes are measured/looked for continuously during treatment/hospital stay.

Overall trial start date

01/05/2008

Overall trial end date

01/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Physician diagnosis of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) as primary cause for admission
2. Able to enter study within 24 hours of admission
3. Age greater than 40 years, male and female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Intensive care unit admission
2. Moribund or not for active treatment
3. Admission expected to last less than 48 hours
4. Unable or unwilling to give informed consent
5. Known type I diabetes mellitus
6. Patients with reduced awareness of hypoglycaemia including reduced Glasgow Coma Scale or those taking beta blockers
6. Patients with renal or hepatic failure at increased risk of hypoglycaemia

Recruitment start date

01/05/2008

Recruitment end date

01/05/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Clinical Pharmacology
London
SW17 0RE
United Kingdom

Sponsor information

Organisation

St George's, University of London (UK)

Sponsor details

Cranmer Terrace
London
SW17 0RE
United Kingdom

Sponsor type

University/education

Website

http://www.sgul.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - NIHR Trainees Programme funds academic clinical fellows

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own consumables

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22021788

Publication citations

  1. Results

    Archer 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, 1, 1, e000210, doi: 10.1136/bmjopen-2011-000210.

Additional files

Editorial Notes