A randomised, double-blind, placebo-controlled trial of metformin in chronic obstructive pulmonary disease (COPD) exacerbations: a pilot study - Metformin in COPD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020818-28-GB

Enrollment

Registered

2010-10-08

Start date

2010-10-14

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease MedDRA version: 14.1 Level: LLT Classification code 10009026 Term: Chronic obstructive airways disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Metformin 500 mg tablets Product Name: Metformin Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Ro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Diagnosis of COPD based on at least one of the following criteria: - Previously recorded airflow obstruction on spirometry (FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The overarching research question for this body of work is to ascertain whether metformin improves recovery from COPD exacerbations. This pilot study will address a more limited question, as a basis for future trial design: in patients admitted to hospital with COPD exacerbations, is metformin an effective treatment for acute hyperglycaemia (elevated blood sugar concentration)? ;Secondary Objective: In patients admitted to hospital with COPD exacerbations, does metformin have beneficial effects on clinical outcome, measures of inflammation, steroid sensitivity, and airflow obstruction, which merit further study?;Primary end point(s): The mean capillary blood glucose concentration during the hospitalisation period	—

Measure

Time frame

Main Objective: The overarching research question for this body of work is to ascertain whether metformin improves recovery from COPD exacerbations. This pilot study will address a more limited question, as a basis for future trial design: in patients admitted to hospital with COPD exacerbations, is metformin an effective treatment for acute hyperglycaemia (elevated blood sugar concentration)? ;Secondary Objective: In patients admitted to hospital with COPD exacerbations, does metformin have beneficial effects on clinical outcome, measures of inflammation, steroid sensitivity, and airflow obstruction, which merit further study?;Primary end point(s): The mean capillary blood glucose concentration during the hospitalisation period

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026