Metformin in chronic obstructive pulmonary disease

ISRCTN	ISRCTN66148745
DOI	https://doi.org/10.1186/ISRCTN66148745
ClinicalTrials.gov (NCT)	NCT01247870
Clinical Trials Information System (CTIS)	2010-020818-28
Protocol serial number	10.0086
Sponsor	St George's, University of London (UK)
Funders	British Lung Foundation (UK) (ref: COPD10/7), Medical Research Council (UK) (ref MR/J010235/1)

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

Primary study design	Interventional
Study design	Randomised multicentre double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Metformin
Primary outcome measure(s)	Mean capillary glucose concentration from study entry to hospital discharge
Key secondary outcome measure(s)	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
Completion date	01/07/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

St George's, University of London

London
SW17 0RE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.