Trial · NCT01447927

Metformin Hydrochloride in Preventing Esophageal Cancer in Patients With Barrett Esophagus

NCT01447927, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-07-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Metformin Hydrochloride in Preventing Esophageal Cancer in Patients With Barrett Esophagus. Trials, record NCT01447927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01447927

On this page

Trial

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

Title: Metformin Hydrochloride in Preventing Esophageal Cancer in Patients With Barrett Esophagus
NCT number: NCT01447927
Status: Completed
Phases: Phase 2
Enrollment: 93 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Barrett Esophagus, Esophageal Cancer
Interventions: metformin hydrochloride, placebo
First posted: 2011-10-06
Last updated: 2014-07-21
Results first posted: 2014-07-21

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Percent Change in Median pS6K1 Immunostaining Among Participants With Barrett Esophagus	Baseline to 3 months	The percent change in pS6K1 was calculated as month 3 pS6k1 values minus baseline pS6k1 values, then divide by baseline pS6k1 values and multiply by 100.
Secondary	Overall Adverse Event Rates	Up to 30 days	Number of patients that experienced adverse events (grade 1 or above) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v. 4.0. The data reported in the table include only the commonly occurring adverse events (3 or more events).

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change in Median pS6K1 Immunostaining Among Participants With Barrett Esophagus	Baseline to 3 months	Participants were considered evaluable for primary endpoint if pS6K1 data were available from both the pre- and post-intervention evaluations based on the intent-to-treat principle.	percentage of change	MEDIAN
SECONDARY	Overall Adverse Event Rates	Up to 30 days		participants	NUMBER

Source ClinicalTrials.gov

Results by group22

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

Outcome	Group	Category	Value	Spread	Units
Percent Change in Median pS6K1 Immunostaining Among Participants With Barrett Esophagus	Metformin		1.4	Full Range 157.1	percentage of change
Percent Change in Median pS6K1 Immunostaining Among Participants With Barrett Esophagus	Placebo		-14.7	Full Range 301.0	percentage of change
Overall Adverse Event Rates	Metformin	Abdominal Pain	6		participants
Overall Adverse Event Rates	Placebo	Abdominal Pain	0		participants
Overall Adverse Event Rates	Metformin	Cough	0		participants
Overall Adverse Event Rates	Placebo	Cough	3		participants
Overall Adverse Event Rates	Metformin	Diarrhea	10		participants
Overall Adverse Event Rates	Placebo	Diarrhea	5		participants
Overall Adverse Event Rates	Metformin	Dyspepsia	2		participants
Overall Adverse Event Rates	Placebo	Dyspepsia	3		participants

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Metformin	38
Overall Study	STARTED	Placebo	36
Overall Study	COMPLETED	Metformin	33
Overall Study	COMPLETED	Placebo	33
Overall Study	NOT COMPLETED	Metformin	5
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events112

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	Anemia	Blood and lymphatic system disorders	Placebo	1	36	1
other	Anemia	Blood and lymphatic system disorders	Metformin	1	38	1
other	Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	Placebo	1	36	2
other	Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	Metformin	0	38	0
other	Abdominal distension	Gastrointestinal disorders	Placebo	1	36	1
other	Abdominal distension	Gastrointestinal disorders	Metformin	0	38	0
other	Abdominal pain	Gastrointestinal disorders	Placebo	0	36	0
other	Abdominal pain	Gastrointestinal disorders	Metformin	6	38	6
other	Bloating	Gastrointestinal disorders	Placebo	0	36	0
other	Bloating	Gastrointestinal disorders	Metformin	1	38	1

1 to 10 of 112Source ClinicalTrials.gov

See all 112 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Metformin
Total, other adverse events	Placebo	23	36
Total, other adverse events	Metformin	26	38
Total, serious adverse events	Placebo	0	36
Total, serious adverse events	Metformin	1	38

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25218668	DERIVED

Source PubMed

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 comparisons1

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

Comparison
Metformin vs Placebo: serious adverse events

Source 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.

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/NCT01447927

GET https://conductscience.org/api/trials/v1/NCT01447927/results?page=2

API reference For AI assistants