Trial Outcomes & Findings for Effects of Metformin on Low Back Pain (NCT NCT04055012)
NCT ID: NCT04055012
Last Updated: 2025-02-21
Results Overview
Scores range from 0 to 10 with a higher score indicating more severe pain
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Up to 15 months
Results posted on
2025-02-21
Participant Flow
Participant milestones
| Measure |
High Dose Metformin
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
Low Dose Metformin
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
|---|---|---|---|---|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
2
|
0
|
|
Overall Study
STARTED
|
8
|
8
|
4
|
3
|
|
Overall Study
COMPLETED
|
6
|
4
|
2
|
3
|
Reasons for withdrawal
| Measure |
High Dose Metformin
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
Low Dose Metformin
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
1
|
0
|
|
Overall Study
Metformin Recall
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Effects of Metformin on Low Back Pain
Baseline characteristics by cohort
| Measure |
High Dose Metformin
n=8 Participants
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
Low Dose Metformin
n=8 Participants
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=4 Participants
High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 Participants
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 16.31826321 • n=5 Participants
|
48 years
STANDARD_DEVIATION 11.86155254 • n=7 Participants
|
42 years
STANDARD_DEVIATION 20.82266393 • n=5 Participants
|
45 years
STANDARD_DEVIATION 16.19670748 • n=4 Participants
|
47 years
STANDARD_DEVIATION 14.83639367 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
23 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 15 monthsScores range from 0 to 10 with a higher score indicating more severe pain
Outcome measures
| Measure |
Low Dose Metformin
n=4 Participants
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=2 Participants
Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 Participants
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
High Dose Metformin
n=6 Participants
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
|---|---|---|---|---|
|
Change From Baseline in Numeric Pain Rating Scale
baseline pain score
|
5.75 score on a scale
Standard Deviation 2.22
|
6 score on a scale
Standard Deviation 2.83
|
2.33 score on a scale
Standard Deviation 2.08
|
5.33 score on a scale
Standard Deviation 1.03
|
|
Change From Baseline in Numeric Pain Rating Scale
change in pain score
|
-1.5 score on a scale
Standard Deviation 0.58
|
-1.5 score on a scale
Standard Deviation 0.71
|
0.33 score on a scale
Standard Deviation 3.06
|
-1.16 score on a scale
Standard Deviation 0.98
|
PRIMARY outcome
Timeframe: Up to 15 monthsScores range from 0% to 100% with higher scores indicating greater disability
Outcome measures
| Measure |
Low Dose Metformin
n=4 Participants
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=2 Participants
Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 Participants
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
High Dose Metformin
n=6 Participants
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
|---|---|---|---|---|
|
Change From Baseline in Oswestry Disability Index (ODI)
average ODI change
|
-2.5 score on a scale
Standard Deviation 12.37
|
-8 score on a scale
Standard Deviation 2.83
|
-8.67 score on a scale
Standard Deviation 10.07
|
-3 score on a scale
Standard Deviation 7.01
|
|
Change From Baseline in Oswestry Disability Index (ODI)
baseline ODI
|
26 score on a scale
Standard Deviation 9.38
|
21 score on a scale
Standard Deviation 1.41
|
20.67 score on a scale
Standard Deviation 10.26
|
23.33 score on a scale
Standard Deviation 4.13
|
SECONDARY outcome
Timeframe: Up to 15 monthsCurrent pain on average reported on 0-10 scale, higher scores indicate greater pain
Outcome measures
| Measure |
Low Dose Metformin
n=4 Participants
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=2 Participants
Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 Participants
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
High Dose Metformin
n=6 Participants
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
|---|---|---|---|---|
|
Change From Baseline in BACPAC (Back Pain Consortium) Minimum Dataset: Pain Outcomes Assessment
|
-1.5 score on a scale
Standard Deviation 1
|
0.5 score on a scale
Standard Deviation 0.71
|
-0.33 score on a scale
Standard Deviation 1.15
|
-1.33 score on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Up to 15 monthsSubject is timed walking at self-selected speed. A faster time (fewer seconds to complete the walk) is associated with better outcome.
Outcome measures
| Measure |
Low Dose Metformin
n=4 Participants
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=2 Participants
Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 Participants
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
High Dose Metformin
n=6 Participants
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
|---|---|---|---|---|
|
Change From Baseline in 10 Meter Walk Test
|
-0.57 seconds
Standard Deviation 1.91
|
-0.73 seconds
Standard Deviation 0.47
|
-0.05 seconds
Standard Deviation 1.26
|
-2.71 seconds
Standard Deviation 5.26
|
SECONDARY outcome
Timeframe: Up to 15 monthsScores range from 0 to 96 in which a higher score indicates greater fear avoidance beliefs
Outcome measures
| Measure |
Low Dose Metformin
n=4 Participants
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=2 Participants
Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 Participants
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
High Dose Metformin
n=6 Participants
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
|---|---|---|---|---|
|
Change From Baseline in Fear Avoidance Questionnaire
|
-0.25 score on a scale
Standard Deviation 8.81
|
-7 score on a scale
Standard Deviation 4.24
|
-5.67 score on a scale
Standard Deviation 3.79
|
-1.67 score on a scale
Standard Deviation 5.20
|
SECONDARY outcome
Timeframe: Up to 15 monthsScores range from 0-9. A higher score indicates higher risk of persisting disabling symptoms.
Outcome measures
| Measure |
Low Dose Metformin
n=4 Participants
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=2 Participants
Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 Participants
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
High Dose Metformin
n=6 Participants
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
|---|---|---|---|---|
|
Change From Baseline in STarT Back Tool
|
-0.5 score on a scale
Standard Deviation 1.29
|
0 score on a scale
Standard Deviation 2.83
|
-0.33 score on a scale
Standard Deviation 3.06
|
-1.83 score on a scale
Standard Deviation 2.40
|
SECONDARY outcome
Timeframe: Up to 15 monthsScore range from 0 to 24 with a higher score indicating a higher degree of catastrophizing
Outcome measures
| Measure |
Low Dose Metformin
n=4 Participants
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=2 Participants
Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 Participants
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
High Dose Metformin
n=6 Participants
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
|---|---|---|---|---|
|
Change From Baseline in 6-item Pain Catastrophizing Scale
|
0.75 score on a scale
Standard Deviation 4.79
|
-2 score on a scale
Standard Deviation 1.41
|
0.33 score on a scale
Standard Deviation 3.79
|
-1.67 score on a scale
Standard Deviation 3.88
|
SECONDARY outcome
Timeframe: Up to 15 monthsFor most PROMIS domains, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher score indicates a more positive outlook.
Outcome measures
| Measure |
Low Dose Metformin
n=4 Participants
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=2 Participants
Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 Participants
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
High Dose Metformin
n=6 Participants
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
|---|---|---|---|---|
|
Change From Baseline in Positive Outlook v1.0 - Short Form 6a
|
0.225 T score
Standard Deviation 5.97
|
-2.55 T score
Standard Deviation 1.20
|
-10.27 T score
Standard Deviation 20.35
|
-1.9 T score
Standard Deviation 5.78
|
SECONDARY outcome
Timeframe: Up to 15 monthsThe PROMIS (Patient-Reported Outcomes Measurement Information System) 29 is a 29 question assessment of 8 domains of health related quality of life (physical function, fatigue, sleep disturbance, pain interference, anxiety, depression, ability to participate in social roles and activities, and cognitive function. For most PROMIS domains, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. Higher T scores indicates greater report of the concept being measured.
Outcome measures
| Measure |
Low Dose Metformin
n=4 Participants
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=2 Participants
Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 Participants
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
High Dose Metformin
n=6 Participants
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
|---|---|---|---|---|
|
Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29
Change from baseline in Physical function
|
-2.075 T score
Standard Deviation 3.089
|
-0.6 T score
Standard Deviation 9.48
|
-1.43 T score
Standard Deviation 2.48
|
-0.62 T score
Standard Deviation 4.26
|
|
Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29
Change from baseline in Anxiety
|
-3.075 T score
Standard Deviation 3.27
|
-6.75 T score
Standard Deviation 1.34
|
-6.63 T score
Standard Deviation 5.75
|
0.55 T score
Standard Deviation 5.32
|
|
Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29
Change from baseline in Depression
|
2.3 T score
Standard Deviation 5.72
|
-1.35 T score
Standard Deviation 5.87
|
-7.8 T score
Standard Deviation 8.17
|
2.25 T score
Standard Deviation 6.97
|
|
Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29
Change from baseline in Fatigue
|
-3.2 T score
Standard Deviation 6.4
|
-0.85 T score
Standard Deviation 6.72
|
0.43 T score
Standard Deviation 6.36
|
-1.35 T score
Standard Deviation 12.90
|
|
Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29
Change from baseline in Sleep disturbance
|
0.275 T score
Standard Deviation 3.24
|
-1.2 T score
Standard Deviation 5.66
|
-1.33 T score
Standard Deviation 1.40
|
1 T score
Standard Deviation 4.76
|
|
Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29
Change from baseline in Ability to participate in social roles and activities in the past 7 days
|
-1.575 T score
Standard Deviation 9.45
|
-3.5 T score
Standard Deviation 4.95
|
1.27 T score
Standard Deviation 2.19
|
-3.1 T score
Standard Deviation 6.44
|
|
Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29
Change from baseline in Pain interference in the past 7 days
|
-4.175 T score
Standard Deviation 7.40
|
-4.8 T score
Standard Deviation 1.70
|
3.07 T score
Standard Deviation 5.31
|
-1.55 T score
Standard Deviation 3.22
|
|
Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29
Change from baseline in Cognitive function-Abilities
|
0 T score
Standard Deviation 6.70
|
-6.75 T score
Standard Deviation 3.61
|
-1.07 T score
Standard Deviation 1.85
|
0 T score
Standard Deviation 13.28
|
SECONDARY outcome
Timeframe: Up to 15 monthsFor most PROMIS domains, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher score indicate higher self efficacy.
Outcome measures
| Measure |
Low Dose Metformin
n=4 Participants
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=2 Participants
Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 Participants
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
High Dose Metformin
n=6 Participants
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
|---|---|---|---|---|
|
Change From Baseline in General Self-Efficacy - Short Form 4a
|
-0.65 T score
Standard Deviation 3.90
|
5.45 T score
Standard Deviation 7.71
|
-8.2 T score
Standard Deviation 9.63
|
-3.97 T score
Standard Deviation 8.01
|
SECONDARY outcome
Timeframe: Up to 15 monthsThis questionnaire developed by the World Health Organization measures physical activity at work or school, household, travel, recreational and sedentary behaviors, measured in MET (metabolic equivalent)-minutes per week (continuous variable).
Outcome measures
| Measure |
Low Dose Metformin
n=4 Participants
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=2 Participants
Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 Participants
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
High Dose Metformin
n=6 Participants
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
|---|---|---|---|---|
|
Change From Baseline in Global Physical Activity Questionnaire
|
-1825 MET- minutes per week
Standard Deviation 2953.0
|
1050 MET- minutes per week
Standard Deviation 551.54
|
-277.33 MET- minutes per week
Standard Deviation 240.71
|
-1100 MET- minutes per week
Standard Deviation 3325.9
|
SECONDARY outcome
Timeframe: Up to 15 monthsScores range from 0 to 45 with a higher score indicating more qualitatively severe and impactful pain.
Outcome measures
| Measure |
Low Dose Metformin
n=4 Participants
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=2 Participants
Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 Participants
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
High Dose Metformin
n=6 Participants
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
|---|---|---|---|---|
|
Change From Baseline in McGill Pain Questionnaire
|
-2.5 score on a scale
Standard Deviation 5.80
|
-3.5 score on a scale
Standard Deviation 2.12
|
-11.67 score on a scale
Standard Deviation 19.86
|
-4.83 score on a scale
Standard Deviation 3.43
|
SECONDARY outcome
Timeframe: Up to 15 monthsMeasures overall health with a higher score more likely predicative of mortality or higher resource use. Scale is scored 0-37.
Outcome measures
| Measure |
Low Dose Metformin
n=4 Participants
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=2 Participants
Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 Participants
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
High Dose Metformin
n=6 Participants
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
|---|---|---|---|---|
|
Change in Charlson Comorbidity Index
|
0.25 score on a scale
Standard Deviation 0.5
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0.17 score on a scale
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Up to 15 monthsMeasures strain of finances. Score ranges from 1-4. The lower the score the harder the financial strain.
Outcome measures
| Measure |
Low Dose Metformin
n=4 Participants
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=2 Participants
Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 Participants
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
High Dose Metformin
n=6 Participants
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
|---|---|---|---|---|
|
Change From Baseline in Financial Strain
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
-0.16 score on a scale
Standard Deviation 0.98
|
Adverse Events
High Dose Metformin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Low Dose Metformin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
High Dose Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Low Dose Placebo
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 |
High Dose Metformin
n=8 participants at risk
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
Low Dose Metformin
n=8 participants at risk
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin: 500mg tabs of Metformin Extended Release
|
High Dose Placebo
n=2 participants at risk
High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Placebo: Placebo Tabs
|
Low Dose Placebo
n=3 participants at risk
Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.
Placebo: Placebo Tabs
|
|---|---|---|---|---|
|
General disorders
Abnormal Lab Value - Low Vitamin B12
|
12.5%
1/8 • Number of events 1 • up to 15 months
|
12.5%
1/8 • Number of events 1 • up to 15 months
|
0.00%
0/2 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
|
General disorders
Abnormal Lab Value - Elevated ESR
|
0.00%
0/8 • up to 15 months
|
12.5%
1/8 • Number of events 1 • up to 15 months
|
0.00%
0/2 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
|
General disorders
Abnormal Lab Value - Low Alkaline Phosphatase
|
12.5%
1/8 • Number of events 1 • up to 15 months
|
0.00%
0/8 • up to 15 months
|
0.00%
0/2 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
|
General disorders
Abnormal Lab Value - Hypoglycemia
|
25.0%
2/8 • Number of events 2 • up to 15 months
|
0.00%
0/8 • up to 15 months
|
0.00%
0/2 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
|
General disorders
Abnormal Lab Value - Elevated CBC
|
12.5%
1/8 • Number of events 1 • up to 15 months
|
0.00%
0/8 • up to 15 months
|
0.00%
0/2 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
|
General disorders
Abnormal Lab Value - Hypercalcemia
|
12.5%
1/8 • Number of events 1 • up to 15 months
|
0.00%
0/8 • up to 15 months
|
0.00%
0/2 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
|
General disorders
Abnormal Lab Value - Elevated Potassium
|
12.5%
1/8 • Number of events 1 • up to 15 months
|
0.00%
0/8 • up to 15 months
|
0.00%
0/2 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
|
General disorders
Low Iron
|
0.00%
0/8 • up to 15 months
|
0.00%
0/8 • up to 15 months
|
50.0%
1/2 • Number of events 1 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
|
Gastrointestinal disorders
Gastrointestinal Discomfort
|
12.5%
1/8 • Number of events 1 • up to 15 months
|
0.00%
0/8 • up to 15 months
|
0.00%
0/2 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2 • up to 15 months
|
25.0%
2/8 • Number of events 2 • up to 15 months
|
0.00%
0/2 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
3/8 • Number of events 3 • up to 15 months
|
25.0%
2/8 • Number of events 2 • up to 15 months
|
0.00%
0/2 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
|
Gastrointestinal disorders
Acid Reflux
|
12.5%
1/8 • Number of events 1 • up to 15 months
|
0.00%
0/8 • up to 15 months
|
0.00%
0/2 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
|
Gastrointestinal disorders
Gas
|
0.00%
0/8 • up to 15 months
|
25.0%
2/8 • Number of events 2 • up to 15 months
|
0.00%
0/2 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • up to 15 months
|
12.5%
1/8 • Number of events 1 • up to 15 months
|
0.00%
0/2 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
|
Gastrointestinal disorders
Abdominal Cramping
|
0.00%
0/8 • up to 15 months
|
0.00%
0/8 • up to 15 months
|
50.0%
1/2 • Number of events 1 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/8 • up to 15 months
|
12.5%
1/8 • Number of events 1 • up to 15 months
|
0.00%
0/2 • up to 15 months
|
33.3%
1/3 • Number of events 1 • up to 15 months
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • up to 15 months
|
50.0%
4/8 • Number of events 5 • up to 15 months
|
0.00%
0/2 • up to 15 months
|
0.00%
0/3 • up to 15 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place