Additional identifiers
EudraCT number
2010-020818-28
ClinicalTrials.gov number
NCT01247870
Protocol/serial number
10.0086
Study information
Scientific title
A randomised, double-blind, placebo-controlled trial of metformin in chronic obstructive pulmonary disease (COPD) exacerbations: a pilot study evaluating anti-hyperglycaemic efficacy
Acronym
Study hypothesis
That metformin is efficacious as a glucose-lowering agent among patients admitted to hospital for chronic obstructive pulmonary disease (COPD) exacerbation.
Ethics approval
South East Research Ethics Committee, 08/09/2010, ref: 10/H1102/62
Study design
Randomised multicentre double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
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
Chronic obstructive pulmonary disease
Intervention
Active: metformin 1 g twice-daily for 28 - 35 days
Comparator: placebo capsules twice-daily for 28 - 35 days
Clinical follow-up is for 1 month (range 28 - 35 days) for both the active and placebo arms.
Intervention type
Drug
Phase
Phase IV
Drug names
Metformin
Primary outcome measure
Mean capillary glucose concentration from study entry to hospital discharge
Secondary outcome measures
Current secondary outcome measures as of 06/03/2014:
1. COPD Assessment Test score, measured at study entry, hospital discharge and follow-up
2. Exacerbation of Chronic Pulmonary Disease Tool (EXACT) score, measured at days 5, 10 and 28
3. Number of days from hospital admission to hospital discharge
4. Recurrent exacerbation, readmission and death rate, measured at 3 months
5. Insulin requirement during hospitalisation period, measured during hospitalisation period following study entry
6. Haemoglobin A1c, measured at follow-up (one month post study entry)
7. C-reactive protein concentration, measured at days 7 and follow-up (one month)
8. Body mass index, measured at follow-up (one month)
9. Waist circumference, measured at follow-up (one month)
10. Forced expiratory volume in 1 second, measured at at hospital discharge and follow-up (one month)
11. Serum fructosamine concentration at discharge and one month
12. Inflammatory cytokine concentrations and markers of oxidative stress at discharge and one month
Previous secondary outcome measures:
1. COPD Assessment Test score, measured at study entry, hospital discharge and follow-up
2. Exacerbation of Chronic Pulmonary Disease Tool (EXACT) score, measured at days 5, 10 and 28
3. Number of days from hospital admission to hospital discharge
4. Recurrent exacerbation, readmission and death rate, measured at 3 months
5. Insulin requirement during hospitalisation period, measured during hospitalisation period following study entry
6. Haemoglobin A1c, measured at follow-up (one month post study entry)
7. C-reactive protein concentration, measured at days 7 and follow-up (one month)
8. Body mass index, measured at follow-up (one month)
9. Waist circumference, measured at follow-up (one month)
10. Forced expiratory volume in 1 second, measured at at hospital discharge and follow-up (one month)
11. Response to cutaneous steroid application (McKenzie test), measured at study day greater than or equal to 5
Overall trial start date
24/01/2011
Overall trial end date
01/07/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 06/03/2014:
1. Pre-existing diagnosis of COPD
2. Admission to hospital principally for an exacerbation of COPD
3. Aged greater than or equal to 35 years
4. Expected to remain in hospital for ≥48 hours
Previous inclusion criteria:
1. Pre-existing diagnosis of COPD
2. Admission to hospital principally for an exacerbation of COPD
3. Aged greater than or equal to 35 years
4. Able to enter the study within 48 hours of admission
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
69
Participant exclusion criteria
1. Prior diagnosis of diabetes mellitus requiring insulin or oral hypoglycaemic therapy
2. Hypersensitivity to metformin hydrochloride or to any of the excipients
3. Renal impairment
4. Severe sepsis
5. Metabolic acidosis
6. Decompensated type 2 respiratory failure
7. Severe congestive cardiac failure
8. Acute coronary syndrome
9. Hepatic insufficiency
10. Excessive alcohol consumption
11. Malnourished or at high risk for malnutrition
12. Moribund or not for active treatment
13. Admitted to critical care unit
14. Unable to give informed consent
15. Pregnancy or lactation
Recruitment start date
24/01/2011
Recruitment end date
01/07/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St George's, University of London
London
SW17 0RE
United Kingdom
Sponsor information
Organisation
St George's, University of London (UK)
Sponsor details
Joint Research Office (mail point H0A)
Cranmer Terrace
London
SW17 0RE
United Kingdom
+44 (0)20 8725 4986
research@sgul.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
British Lung Foundation (UK) (ref: COPD10/7)
Alternative name(s)
BLF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Funder name
Medical Research Council (UK) (ref MR/J010235/1)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26917577