Metformin in chronic obstructive pulmonary disease

ISRCTN	ISRCTN66148745
DOI	https://doi.org/10.1186/ISRCTN66148745
EudraCT/CTIS number	2010-020818-28
ClinicalTrials.gov number	NCT01247870
Secondary identifying numbers	10.0086

Submission date: 18/01/2011
Registration date: 17/03/2011
Last edited: 29/02/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Emma Baker
Scientific

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

Study information

Study design	Randomised multicentre double-blind placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	That metformin is efficacious as a glucose-lowering agent among patients admitted to hospital for chronic obstructive pulmonary disease (COPD) exacerbation.
Ethics approval(s)	South East Research Ethics Committee, 08/09/2010, ref: 10/H1102/62
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	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 study start date	24/01/2011
Completion date	01/07/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	69
Key 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
Key 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
Date of first enrolment	24/01/2011
Date of final enrolment	01/07/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St George's, University of London

London
SW17 0RE
United Kingdom

Sponsor information

St George's, University of London (UK)
University/education

Joint Research Office (mail point H0A)
Cranmer Terrace
London
SW17 0RE
England
United Kingdom

Phone	+44 (0)20 8725 4986
Email	research@sgul.ac.uk
Website	http://www.sgul.ac.uk/research/about-research-at-st-georges
"ROR"	https://ror.org/040f08y74

Funders

Funder type

Charity

British Lung Foundation (UK) (ref: COPD10/7)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): BLF
Location: United Kingdom

Medical Research Council (UK) (ref MR/J010235/1)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2016		Yes	No
HRA research summary			28/06/2023	No	No

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.