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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sputum Glucose Concentration | 3 months | The median concentration of glucose in sputum following 3 months treatment with metformin or placebo. |
| Secondary | Nasal Glucose Concentrations | 3 months | The median concentration of glucose in nasal samples following 3 months treatment with metformin or placebo. |
| Secondary | Sputum Bacterial Load | 3 months | The bacterial load in sputum using qPCR was not measured. Therefore, data were not collected |
| Secondary | Sputum Inflammatory Markers | 3 months | The median concentration of inflammatory cells and cytokines in sputum was not measured. Therefore, data were not collected. |
| Secondary | Quality 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. |
| Secondary | Quality 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. |
| Secondary | Lung Function | 1 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sputum Glucose Concentration | 3 months | µM | MEDIAN | |
| SECONDARY | Nasal Glucose Concentrations | 3 months | µM | MEDIAN | |
| SECONDARY | Sputum Bacterial Load | 3 months | Data were not collected. Participants with infection were excluded from the study. | ||
| SECONDARY | Sputum Inflammatory Markers | 3 months | Data were not collected. Participants with infection were excluded from the study. | ||
| SECONDARY | Quality of Life Score (COPD Assessment Test) | 1 month | Score on a scale | MEDIAN | |
| SECONDARY | Quality of Life Score (St George's Respiratory Questionnaire) | 1 month | Score on a scale | MEDIAN | |
| SECONDARY | Lung Function | 1 month | Litres (L) | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sputum Glucose Concentration | Treatment Group | 68.92 | Inter-Quartile Range 16.3 to 131.1 | µM | |
| Sputum Glucose Concentration | Placebo Group | 12.2 | Inter-Quartile Range 10 to 13 | µM | |
| Nasal Glucose Concentrations | Treatment Group | 12.56 | Inter-Quartile Range 5.92 to 28.28 | µM | |
| Nasal Glucose Concentrations | Placebo Group | 13.5 | Inter-Quartile Range 6.19 to 27.83 | µM | |
| Quality of Life Score (COPD Assessment Test) | Treatment Group | 16.6 | Inter-Quartile Range 6.4 to 26.8 | Score on a scale | |
| Quality of Life Score (COPD Assessment Test) | Placebo Group | 13.2 | Inter-Quartile Range 3.3 to 23.1 | Score on a scale | |
| Quality of Life Score (St George's Respiratory Questionnaire) | Treatment Group | 42.7 | Inter-Quartile Range 24.4 to 61 | Score on a scale | |
| Quality of Life Score (St George's Respiratory Questionnaire) | Placebo Group | 36.4 | Inter-Quartile Range 18.6 to 54.2 | Score on a scale | |
| Lung Function | Treatment Group | 69.2 | Inter-Quartile Range 51 to 87.4 | Litres (L) | |
| Lung Function | Placebo Group | 66.1 | Inter-Quartile Range 46.7 to 85.5 | Litres (L) |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Drug Assignment | STARTED | Metformin First (Before Crossover), Placebo Second (After Crossover) | 7 | |
| First Drug Assignment | STARTED | Placebo First (Before Crossover), Metformin Second (After Crossover) | 7 | |
| First Drug Assignment | 1 Month | Metformin First (Before Crossover), Placebo Second (After Crossover) | 6 | |
| First Drug Assignment | 1 Month | Placebo First (Before Crossover), Metformin Second (After Crossover) | 6 | |
| First Drug Assignment | 3 Months | Metformin First (Before Crossover), Placebo Second (After Crossover) | 3 | |
| First Drug Assignment | 3 Months | Placebo First (Before Crossover), Metformin Second (After Crossover) | 2 | |
| First Drug Assignment | COMPLETED | Metformin First (Before Crossover), Placebo Second (After Crossover) | 3 | |
| First Drug Assignment | COMPLETED | Placebo First (Before Crossover), Metformin Second (After Crossover) | 2 | |
| First Drug Assignment | NOT COMPLETED | Metformin First (Before Crossover), Placebo Second (After Crossover) | 4 | |
| First Drug Assignment | NOT COMPLETED | Placebo First (Before Crossover), Metformin Second (After Crossover) | 5 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Treatment Group | 2 | 14 | |
| other | Nausea | Gastrointestinal disorders | Placebo Group | 0 | 14 | |
| other | Vomiting | Gastrointestinal disorders | Treatment Group | 1 | 14 | |
| other | Vomiting | Gastrointestinal disorders | Placebo Group | 1 | 14 | |
| other | Diarrhoea | Gastrointestinal disorders | Treatment Group | 2 | 14 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Group | 1 | 14 | |
| other | Abdominal cramps | Gastrointestinal disorders | Treatment Group | 1 | 14 | |
| other | Abdominal cramps | Gastrointestinal disorders | Placebo Group | 0 | 14 | |
| other | Lower respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Treatment Group | 3 | 14 | |
| other | Lower respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Placebo Group | 3 | 14 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Group | 0 | 14 |
| Total, all-cause mortality | Placebo Group | 0 | 14 |
| Total, other adverse events | Treatment Group | 7 | 14 |
| Total, other adverse events | Placebo Group | 7 | 14 |
| Total, serious adverse events | Treatment Group | 0 | 14 |
| Total, serious adverse events | Placebo Group | 1 | 14 |
Source ClinicalTrials.gov
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.
| Comparison | Source |
|---|---|
| Treatment Group vs Placebo Group: deaths from any cause | Trial comparisons |
| Treatment Group vs Placebo Group: serious adverse events | Trial 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.
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