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Trial · NCT03651895

Metformin to Reduce Airway Glucose in COPD Patients

NCT03651895, Phase 2, Completed, Imperial College London; results first posted 2025-02-18

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Metformin to Reduce Airway Glucose in COPD Patients. Trials, record NCT03651895. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03651895

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Metformin to Reduce Airway Glucose in COPD Patients
NCT number
NCT03651895
Status
Completed
Phases
Phase 2
Enrollment
14 participants, actual
Lead sponsor
Imperial College London
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
Metformin, Placebo
First posted
2018-08-29
Last updated
2025-02-18
Other registries' IDs
eudract:2018-001755-12
Results first posted
2025-02-18

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySputum Glucose Concentration3 monthsThe median concentration of glucose in sputum following 3 months treatment with metformin or placebo.
SecondaryNasal Glucose Concentrations3 monthsThe median concentration of glucose in nasal samples following 3 months treatment with metformin or placebo.
SecondarySputum Bacterial Load3 monthsThe bacterial load in sputum using qPCR was not measured. Therefore, data were not collected
SecondarySputum Inflammatory Markers3 monthsThe median concentration of inflammatory cells and cytokines in sputum was not measured. Therefore, data were not collected.
SecondaryQuality of Life Score (COPD Assessment Test)1 month
The COPD Assessment Test (CAT): the CAT features 8 questions ranked from 0-5 with a minimum score of 0 and maximum possible score of 40. Higher scores indicate a greater impact on patient health due to their COPD, a difference of ≥2 is considered meaningful. The questionnaire's were completed by every participant at every visit up to 8 times: V1 is at the baseline, then V2-4 are at monthly intervals. V5 is at the baseline after crossing arms -1 month washout, V6-8 are monthly after that.
SecondaryQuality of Life Score (St George's Respiratory Questionnaire)1 month
St George's Respiratory Questionnaire (SGRQ): the SGRQ contains 50 items with a minimum score of 0 and a maximum score of 100. Higher scores indicate a greater impact on quality of life due to COPD and a difference of ≥4 is meaningful The questionnaire's were completed by every participant at every visit up to 8 times: V1 is at the baseline, then V2-4 are at monthly intervals. V5 is at the baseline after crossing arms -1 month washout, V6-8 are monthly after that.
SecondaryLung Function1 month
FEV1(Forced Expiratory Volume Test) was performed up to 8 times: V1 is at the baseline, then V2-4 are at monthly intervals. V5 is at the baseline after crossing arms -1 month washout, V6-8 are monthly after that.

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYSputum Glucose Concentration3 monthsµMMEDIAN
SECONDARYNasal Glucose Concentrations3 monthsµMMEDIAN
SECONDARYSputum Bacterial Load3 monthsData were not collected. Participants with infection were excluded from the study.
SECONDARYSputum Inflammatory Markers3 monthsData were not collected. Participants with infection were excluded from the study.
SECONDARYQuality of Life Score (COPD Assessment Test)1 monthScore on a scaleMEDIAN
SECONDARYQuality of Life Score (St George's Respiratory Questionnaire)1 monthScore on a scaleMEDIAN
SECONDARYLung Function1 monthLitres (L)MEDIAN

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Sputum Glucose ConcentrationTreatment Group68.92Inter-Quartile Range 16.3 to 131.1µM
Sputum Glucose ConcentrationPlacebo Group12.2Inter-Quartile Range 10 to 13µM
Nasal Glucose ConcentrationsTreatment Group12.56Inter-Quartile Range 5.92 to 28.28µM
Nasal Glucose ConcentrationsPlacebo Group13.5Inter-Quartile Range 6.19 to 27.83µM
Quality of Life Score (COPD Assessment Test)Treatment Group16.6Inter-Quartile Range 6.4 to 26.8Score on a scale
Quality of Life Score (COPD Assessment Test)Placebo Group13.2Inter-Quartile Range 3.3 to 23.1Score on a scale
Quality of Life Score (St George's Respiratory Questionnaire)Treatment Group42.7Inter-Quartile Range 24.4 to 61Score on a scale
Quality of Life Score (St George's Respiratory Questionnaire)Placebo Group36.4Inter-Quartile Range 18.6 to 54.2Score on a scale
Lung FunctionTreatment Group69.2Inter-Quartile Range 51 to 87.4Litres (L)
Lung FunctionPlacebo Group66.1Inter-Quartile Range 46.7 to 85.5Litres (L)

Participant flow18

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
First Drug AssignmentSTARTEDMetformin First (Before Crossover), Placebo Second (After Crossover)7
First Drug AssignmentSTARTEDPlacebo First (Before Crossover), Metformin Second (After Crossover)7
First Drug Assignment1 MonthMetformin First (Before Crossover), Placebo Second (After Crossover)6
First Drug Assignment1 MonthPlacebo First (Before Crossover), Metformin Second (After Crossover)6
First Drug Assignment3 MonthsMetformin First (Before Crossover), Placebo Second (After Crossover)3
First Drug Assignment3 MonthsPlacebo First (Before Crossover), Metformin Second (After Crossover)2
First Drug AssignmentCOMPLETEDMetformin First (Before Crossover), Placebo Second (After Crossover)3
First Drug AssignmentCOMPLETEDPlacebo First (Before Crossover), Metformin Second (After Crossover)2
First Drug AssignmentNOT COMPLETEDMetformin First (Before Crossover), Placebo Second (After Crossover)4
First Drug AssignmentNOT COMPLETEDPlacebo First (Before Crossover), Metformin Second (After Crossover)5

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherNauseaGastrointestinal disordersTreatment Group214
otherNauseaGastrointestinal disordersPlacebo Group014
otherVomitingGastrointestinal disordersTreatment Group114
otherVomitingGastrointestinal disordersPlacebo Group114
otherDiarrhoeaGastrointestinal disordersTreatment Group214
otherDiarrhoeaGastrointestinal disordersPlacebo Group114
otherAbdominal crampsGastrointestinal disordersTreatment Group114
otherAbdominal crampsGastrointestinal disordersPlacebo Group014
otherLower respiratory tract infectionRespiratory, thoracic and mediastinal disordersTreatment Group314
otherLower respiratory tract infectionRespiratory, thoracic and mediastinal disordersPlacebo Group314

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityTreatment Group014
Total, all-cause mortalityPlacebo Group014
Total, other adverse eventsTreatment Group714
Total, other adverse eventsPlacebo Group714
Total, serious adverse eventsTreatment Group014
Total, serious adverse eventsPlacebo Group114

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Treatment Group vs Placebo Group: deaths from any causeTrial comparisons
Treatment Group vs Placebo Group: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03651895

GET https://conductscience.org/api/trials/v1/NCT03651895/registered