Trial Outcomes & Findings for Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth (NCT NCT01632020)
NCT ID: NCT01632020
Last Updated: 2016-07-11
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
10-21 days
Results posted on
2016-07-11
Participant Flow
Study was open for enrollment between 7/13/2012 and 3/5/2014. Subjects were recruited from medical clinics at the University of Arkansas for Medical Sciences (UAMS) and the Central Arkansas Veterans Healthcare System (CAVHS).
There were no significant events following participant enrollment, prior to group assignment.
Participant milestones
| Measure |
Placebo
Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
|
Metformin
Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
|
Metformin
Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth
Baseline characteristics by cohort
| Measure |
Placebo
n=2 Participants
Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
|
Metformin
n=3 Participants
Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=99 Participants
|
44 years
n=107 Participants
|
49 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 10-21 daysPopulation: Data not collected due to inadequate subject accrual. Analysis not completed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 10-21 daysPopulation: Data not collected due to inadequate subject accrual. Analysis not completed.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Metformin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=4 participants at risk
Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
|
Metformin
n=3 participants at risk
Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdomen Pain Not Otherwise Specified
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain of the extremities/ limbs
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place