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Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth

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ClinicalTrials.gov Identifier: NCT01632020
Recruitment Status : Terminated (Inadequate accrual)
First Posted : June 29, 2012
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Colorectal Neoplasms
Interventions Drug: Placebo
Drug: Metformin
Enrollment 7
Recruitment Details 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).
Pre-assignment Details There were no significant events following participant enrollment, prior to group assignment.
Arm/Group Title Placebo Metformin
Hide Arm/Group Description Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
Period Title: Overall Study
Started 4 3
Completed 2 3
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             1             0
Adverse Event             1             0
Arm/Group Title Placebo Metformin Total
Hide Arm/Group Description Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days Total of all reporting groups
Overall Number of Baseline Participants 2 3 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants 3 participants 5 participants
57
(52 to 61)
44
(37 to 54)
49
(37 to 61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
2
 100.0%
3
 100.0%
5
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
2
 100.0%
3
 100.0%
5
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  50.0%
1
  33.3%
2
  40.0%
White
1
  50.0%
2
  66.7%
3
  60.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 3 participants 5 participants
2 3 5
1.Primary Outcome
Title Proliferation Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy
Hide Description [Not Specified]
Time Frame 10-21 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected due to inadequate subject accrual. Analysis not completed.
Arm/Group Title Placebo Metformin
Hide Arm/Group Description:
Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Mucosal Apoptotic Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy
Hide Description [Not Specified]
Time Frame 10-21 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected due to inadequate subject accrual. Analysis not completed.
Arm/Group Title Placebo Metformin
Hide Arm/Group Description:
Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Metformin
Hide Arm/Group Description Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
All-Cause Mortality
Placebo Metformin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/4 (50.00%)      1/3 (33.33%)    
Blood and lymphatic system disorders     
Anemia *  0/4 (0.00%)  0 1/3 (33.33%)  1
Gastrointestinal disorders     
Nausea *  2/4 (50.00%)  2 0/3 (0.00%)  0
Diarrhea *  1/4 (25.00%)  1 0/3 (0.00%)  0
Abdomen Pain Not Otherwise Specified *  0/4 (0.00%)  0 1/3 (33.33%)  1
Musculoskeletal and connective tissue disorders     
Pain of the extremities/ limbs *  1/4 (25.00%)  1 1/3 (33.33%)  1
*
Indicates events were collected by non-systematic assessment
Early termination leading to small numbers of subjects. Outcome measures not computed because data would not be statistically relevant.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Daisy Wade
Organization: University of Arkansas for Medical Sciences
Phone: 5016868274
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01632020     History of Changes
Other Study ID Numbers: 134190
First Submitted: June 27, 2012
First Posted: June 29, 2012
Results First Submitted: February 19, 2016
Results First Posted: July 11, 2016
Last Update Posted: July 11, 2016