Not yet recruitingNCT06999343AMICOUpdated May 31, 2025

Exploring the Anti-ageing Effects of Metformin in COPD

A Phase 3 interventional study of Metformin 850Mg Tab and Placebo in COPD, sponsored by Fundación Instituto de Investigación Sanitaria de Navarra. Not yet recruiting. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Fundación Instituto de Investigación Sanitaria de Navarra · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 212
Allocation: Randomized
Ages: 40 Years to 75 Years
Sex: All

Study summary

Prospective, multicentre, double-blind, placebo-controlled, randomised, prospective clinical trial comparing the effect of metformin 850 mg twice daily with placebo in COPD patients with evidence of emphysema (by CT scan or reduced DLCO) who are known to have a rapid decrease in FEV1.

Main objective:

To compare the change in FEV1 at 3 years follow-up in patients receiving metformin versus placebo.

Participants will take metformin (850mg) or placebo twice daily for 3 years.

Conditions studied

COPD

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Pulmonary Disease, Chronic Obstructive 4,252

In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's planned enrollment of 212 is above the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

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Lead sponsor

This is the only study on the registry with Fundación Instituto de Investigación Sanitaria de Navarra as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Sign the informed consent form prior to any study-specific procedure.
Male or female, aged 40 to 75 years, inclusive, at the time of Screening.
Have a COPD clinic diagnostic according to Global Initiative for Obstructive Lung Disease (GOLD) 2022 with a post-bronchodilator FEV1/FVC \<0.7 at Screening (Visit 1)
Have a post-bronchodilator FEV1 >40% ≤ 70% of the predicted value at Screening (Visit 1)
Smoking history of more than 10 pack/years ([number of cigarettes smoked per day x number of years smoked]/20)
Must have been able to understand and comply with the requirements of the study, as judged by the investigator.
Have some kind of emphysema (centrolobulillar or paraseptal) reported by an expert radiologist.
Have a certified decrease of the Lung Function in the last 3 years >40 ml/ml per year of FEV1.
Women in childbearing age with negative pregnancy test.

Exclusion criteria

Exclusion Criteria:

Participating in another clinic trial with any commercially or investigational biological medicinal product within 4 months prior to Screening.
Patients who take oral corticosteroids chronically.
Respiratory track infection history (superior respiratory tract included) and pulmonary exarcerbation within 6 weeks prior to Screening.
Lung resection or lung volume reduction surgery within 12 months prior to Screening (Visit 1), or lung trasplant history, or, as judged by the investigator, patient may have required a thoracotomy or other lung surgery during the study.
Known active tuberculosis.
History of intersticial lung or massive pulmonary thromboembolic disease.
History of bronchiectasis secondary to respiratory diseasesother than COPD (e.g. cystic fibrosis, Kartagener's syndrome, etc.).
Any clinically significant disease or disorder (e.g. cardiovascular, gastrointestinal, hepatic, renal (GFR \< 30 ml/min), neurological, musculoskeletal, endocrine, metabolic, psychiatric, and major physical impairment) that, in the opinion of the investigator, could have placed the patient at risk for participation in the study, could have influenced the study results, or could have affected the patient's ability to participate in the study.
Recent history (within 12 months prior to screening [Visit 1]) of myocardial infarction, recent history of heart failure (New York Heart Association [NYHA] classes III and IV), pulmonary oedema and/or cardiac arrhythmia.
History of cancer (within 5 years prior to Visit 1), except non-metastatic skin cancer and non-melanoma.
Patients who cannot perform spirometry manoeuvres or tolerate plethysmography.
Contraindications to the use of metformin: allergy to the drug, advanced renal failure (CKD stage 3 and above), patients on dialysis, chronic metabolic or respiratory acidosis or liver cirrhosis.
Patients with type 2 Diabetes Mellitus with or without previous use of metformin.
Pregnant women, nursing mothers or women of childbearing age who are not going to use contraceptive methods.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 212 participants (estimated)

Study arms

Experimental
Experimental treatment
Experimental treatment: Metformin Tolerance phase dose: 850mg/24h for 2 weeks. Treatment dose: 1700mg twice daily. Pharmaceutical form: 850 mg oral tablet. Duration of treatment: Treatment will last for 3 years.
Drug: Metformin 850Mg Tab
Placebo comparator
Control treatment
Control treatment: Placebo Tolerance phase dose: One tablet/24h for 2 weeks. Treatment dose: Two tablets twice a day. Pharmaceutical form: Tablets with the same appearance as metformin tablets. Duration of treatment: Treatment will last for 3 years.
Other: Placebo

Interventions

DrugMetformin 850Mg Tab
Tolerance phase dose: 850mg/24h for 2 weeks. Treatment dose: 1700 mg twice daily.
OtherPlacebo
Tolerance phase dose: One tablet/24h for 2 weeks. Treatment dose: Two tablets twice daily.

What researchers measure

Primary outcomes

Forced expiratory volume in the first second (FEV1)
The amount of air expelled during the first second of a maximal expiration, performed after a maximal inspiration.
Time frame: At inclusion and at 3-years follow-up
Carbon monoxide diffusion test (DLCO)
Pulmonary function test, in which the diffusion of gases through the pulmonary alveoli into the blood is studied.
Time frame: At inclusion and at 3-years follow-up

Secondary outcomes

Age
Years
Time frame: Baseline
Sex at birth
Male/Female
Time frame: Baseline
Height
Centimetres
Time frame: Baseline
Weight
Kg
Time frame: Baseline and at 1 year, 2 years and 3 years
Smoking
Cigarette packs/year
Time frame: Baseline
The percentage of lung volume with emphysema measured on a chest CT scan.
Time frame: At inclusion and at 3-years follow-up
6-minute walk distance (6MWT)
Metres in 6 minutes
Time frame: Baseline and at 1 year, 2 years and 3 years
Grip strength with dynamometer
Kg
Time frame: Baseline and at 1 year, 2 years and 3 years
BODE Index
The BODE index will result in a score of zero to ten dependent upon FEV1, body-mass index, the distance walked in six minutes, and the modified MRC dyspnea scale where 0 is the best state of health and 10 is the worst.
Time frame: Baseline and month 6, 12, 18, 24, 30 and 36
Dyspnoea
1, 2, 3, 4 or 5 grades where dyspnoea grade 1 is the best state of health and grade 5 is the worst state of health
Time frame: Baseline and at 1 year, 2 years and 3 years
Major cardiovascular events
Select from a list (Myocardial infarction/new angina/stroke) if any of these events happen.
Time frame: Month 6, 12, 18, 24, 30 and 36
Cancer events
Solid cancers Yes/No
Time frame: Month 6, 12, 18, 24, 30 and 36
Renal dysfunction (microalbuminuria)
mg/g
Time frame: Month 6, 12, 18, 24, 30 and 36
Concomitant treatment
EPOC concomitant treatment
Time frame: Month 6, 12, 18, 24, 30 and 36
Exacerbations
YES/NO
Time frame: Month 6, 12, 18, 24, 30 and 36
Emergency room visits
YES/NO
Time frame: Month 6, 12, 18, 24, 30 and 36
Hospitalisations
YES/NO
Time frame: Month 6, 12, 18, 24, 30 and 36
Intubation
YES/NO
Time frame: Month 6, 12, 18, 24, 30 and 36
Obstruction
YES/NO
Time frame: Month 6, 12, 18, 24, 30 and 36

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06999343
Lead sponsor: Fundación Instituto de Investigación Sanitaria de Navarra
Responsible party: Sponsor
First posted: May 31, 2025
Start date: Sep 1, 2025 (estimated)
Primary completion: May 1, 2029 (estimated)
Completion: Sep 1, 2029 (estimated)
Last update: May 31, 2025

Study contacts

Alberto Labiano Tabar

Contact

alberto.labiano.tabar@navarra.es

+34 848 42 32 36

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Metformin

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