Condition category
Respiratory
Date applied
18/01/2011
Date assigned
17/03/2011
Last edited
29/02/2016
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

Prof Emma Baker

ORCID ID

Contact details

Mail point J1A
Division of Biomedical Sciences
St George's
University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom

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 measures

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

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

http://www.sgul.ac.uk/research/about-research-at-st-georges

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

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26917577

Publication citations

Additional files

Editorial Notes

26/02/2016: Publication reference added. Added 12/08/2015: The registration was initiated on 18/01/2011 and finalised on 17/03/2011. Following the prospective submission on 18/01/2011, there were no subsequent changes to the protocol. The recruitment started on 24/01/2011, after initiation of public registration. On 06/03/2014 the following changes were made to the trial record: 1. The overall trial end date was changed from 30/09/2011 to 01/07/2014. 2. The target number of participants was changed from 46 to 69. 3. Medical Research Council (UK) was added to the sourced of funding.