Trial Outcomes & Findings for ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin) (NCT NCT06042855)
NCT ID: NCT06042855
Last Updated: 2025-11-18
Results Overview
Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3214 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2025-11-18
Participant Flow
Participant milestones
| Measure |
Arm G - Metformin
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Overall Study
STARTED
|
1550
|
1664
|
|
Overall Study
COMPLETED
|
1443
|
1548
|
|
Overall Study
NOT COMPLETED
|
107
|
116
|
Reasons for withdrawal
| Measure |
Arm G - Metformin
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Overall Study
No Receipt of Study Drug
|
48
|
57
|
|
Overall Study
Administratively Withdrawn
|
59
|
59
|
Baseline Characteristics
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
Baseline characteristics by cohort
| Measure |
Arm G - Metformin
n=1443 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1548 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Total
n=2991 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.0 years
n=202 Participants
|
48.0 years
n=283 Participants
|
47.0 years
n=120 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Female
|
918 Participants
n=202 Participants
|
977 Participants
n=283 Participants
|
1895 Participants
n=120 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Male
|
522 Participants
n=202 Participants
|
566 Participants
n=283 Participants
|
1088 Participants
n=120 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Undifferentiated
|
1 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
2 Participants
n=120 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Prefer not to answer the question
|
2 Participants
n=202 Participants
|
4 Participants
n=283 Participants
|
6 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
680 Participants
n=202 Participants
|
712 Participants
n=283 Participants
|
1392 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
763 Participants
n=202 Participants
|
836 Participants
n=283 Participants
|
1599 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
6 Participants
n=202 Participants
|
4 Participants
n=283 Participants
|
10 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
30 Participants
n=202 Participants
|
35 Participants
n=283 Participants
|
65 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Race · Black, African American, or African
|
151 Participants
n=202 Participants
|
180 Participants
n=283 Participants
|
331 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Race · Middle Eastern or North African
|
27 Participants
n=202 Participants
|
20 Participants
n=283 Participants
|
47 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=202 Participants
|
3 Participants
n=283 Participants
|
4 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
1129 Participants
n=202 Participants
|
1217 Participants
n=283 Participants
|
2346 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
38 Participants
n=202 Participants
|
17 Participants
n=283 Participants
|
55 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Race · None of the above
|
31 Participants
n=202 Participants
|
37 Participants
n=283 Participants
|
68 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Race · Prefer not to answer
|
25 Participants
n=202 Participants
|
28 Participants
n=283 Participants
|
53 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Race · No response
|
5 Participants
n=202 Participants
|
7 Participants
n=283 Participants
|
12 Participants
n=120 Participants
|
|
Region of Enrollment
United States
|
1443 Participants
n=202 Participants
|
1548 Participants
n=283 Participants
|
2991 Participants
n=120 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Participants with sustained recovery.
Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.
Outcome measures
| Measure |
Arm G - Metformin
n=1416 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1504 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Time to Sustained Recovery in Days
|
9 days
Interval 9.0 to 10.0
|
10 days
Interval 9.0 to 10.0
|
PRIMARY outcome
Timeframe: Up to 28 daysOutcome measures
| Measure |
Arm G - Metformin
n=1443 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1548 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Number of Participants With Hospitalization or Death
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysOutcome measures
| Measure |
Arm G - Metformin
n=1443 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1548 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Number of Participants With Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Data not collected due to no participants having mortality.
Time to mortality was the number of days between drug receipt and death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysOutcome measures
| Measure |
Arm G - Metformin
n=1443 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1548 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death
|
54 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: Participants with COVID clinical progression scale data available.
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Outcome measures
| Measure |
Arm G - Metformin
n=1397 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1487 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
0 = No clinical or virological evidence of infection
|
90 Participants
|
94 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
1 = No limitation of activities
|
1230 Participants
|
1307 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
2 = Limitation of activities
|
77 Participants
|
86 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
3 = Hospitalized
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
4 = Hospitalized, on oxygen by mask or nasal prongs
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
5 = Hospitalized, on non-invasive ventilation or high-flow oxygen
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
6 = Hospitalized, on intubation and mechanical ventilation
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO)
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
8 = Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: Participants who had COVID clinical progression scale data available.
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Outcome measures
| Measure |
Arm G - Metformin
n=1354 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1458 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
0 = No clinical or virological evidence of infection
|
79 Participants
|
80 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
1 = No limitation of activities
|
1237 Participants
|
1333 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
2 = Limitation of activities
|
37 Participants
|
45 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
3 = Hospitalized, no oxygen therapy
|
1 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
4 = Hospitalized, on oxygen by mask or nasal prongs
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
5 = Hospitalized, on non-invasive ventilation or high-flow oxygen
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
6 = Hospitalized, on intubation and mechanical ventilation
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO)
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
8 = Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Participants who had COVID clinical progression scale data available.
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Outcome measures
| Measure |
Arm G - Metformin
n=1315 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1418 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
0 = No clinical or virological evidence of infection
|
78 Participants
|
74 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
1 = No limitation of activities
|
1221 Participants
|
1322 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
2 = Limitation of activities
|
16 Participants
|
22 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
3 = Hospitalized, no oxygen therapy
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
4 = Hospitalized, on oxygen by mask or nasal prongs
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
5 = Hospitalized, on non-invasive ventilation or high-flow oxygen
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
6 = Hospitalized, on intubation and mechanical ventilation
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO)
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
8 = Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 90, 120, and 180Population: Participants with data collected at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for physical function.
Outcome measures
| Measure |
Arm G - Metformin
n=1443 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1548 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 7
|
20 score on a scale
Interval 17.0 to 20.0
|
20 score on a scale
Interval 18.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 14
|
20 score on a scale
Interval 20.0 to 20.0
|
20 score on a scale
Interval 20.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 28
|
20 score on a scale
Interval 20.0 to 20.0
|
20 score on a scale
Interval 20.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 90
|
20 score on a scale
Interval 20.0 to 20.0
|
20 score on a scale
Interval 20.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 120
|
20 score on a scale
Interval 20.0 to 20.0
|
20 score on a scale
Interval 20.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 180
|
20 score on a scale
Interval 20.0 to 20.0
|
20 score on a scale
Interval 20.0 to 20.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 90, 120, and 180Population: Participants with data collected at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for fatigue.
Outcome measures
| Measure |
Arm G - Metformin
n=1443 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1548 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 7
|
7 score on a scale
Interval 4.0 to 11.0
|
7 score on a scale
Interval 4.0 to 11.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 14
|
4 score on a scale
Interval 4.0 to 8.0
|
4 score on a scale
Interval 4.0 to 8.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 28
|
4 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 7.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 90
|
4 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 8.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 120
|
4 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 8.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 180
|
4 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 8.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 90, 120, and 180Population: Participants with data collected at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for pain.
Outcome measures
| Measure |
Arm G - Metformin
n=1443 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1548 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 7
|
4 score on a scale
Interval 4.0 to 8.0
|
4 score on a scale
Interval 4.0 to 8.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 14
|
4 score on a scale
Interval 4.0 to 6.0
|
4 score on a scale
Interval 4.0 to 6.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 28
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 90
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 120
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 180
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 90, 120, and 180Population: Participants with data collected at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for depression.
Outcome measures
| Measure |
Arm G - Metformin
n=1443 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1548 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 7
|
4 score on a scale
Interval 4.0 to 6.0
|
4 score on a scale
Interval 4.0 to 5.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 14
|
4 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 5.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 28
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 90
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 120
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 180
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 90, 120, and 180Population: Participants with data collected at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for anxiety.
Outcome measures
| Measure |
Arm G - Metformin
n=1306 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1392 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 7
|
4 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 6.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 14
|
4 score on a scale
Interval 4.0 to 5.75
|
4 score on a scale
Interval 4.0 to 5.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 28
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 5.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 90
|
4 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 5.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 120
|
4 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 5.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 180
|
4 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 5.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 90, 120, and 180Population: Participants with data collected at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a higher score correlates to better outcome for social roles and activities.
Outcome measures
| Measure |
Arm G - Metformin
n=1303 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1392 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 7
|
20 score on a scale
Interval 15.0 to 20.0
|
20 score on a scale
Interval 15.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 14
|
20 score on a scale
Interval 17.0 to 20.0
|
20 score on a scale
Interval 16.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 28
|
20 score on a scale
Interval 19.0 to 20.0
|
20 score on a scale
Interval 19.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 90
|
20 score on a scale
Interval 19.0 to 20.0
|
20 score on a scale
Interval 19.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 120
|
20 score on a scale
Interval 20.0 to 20.0
|
20 score on a scale
Interval 19.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 180
|
20 score on a scale
Interval 19.0 to 20.0
|
20 score on a scale
Interval 19.0 to 20.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 90, 120, and 180Population: Participants with data collected at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for sleep.
Outcome measures
| Measure |
Arm G - Metformin
n=1304 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1392 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Day 7
|
9 score on a scale
Interval 7.0 to 12.0
|
9 score on a scale
Interval 7.0 to 12.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Day 14
|
8 score on a scale
Interval 6.0 to 11.0
|
8 score on a scale
Interval 6.0 to 11.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Day 28
|
8 score on a scale
Interval 6.0 to 10.0
|
8 score on a scale
Interval 6.0 to 10.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Day 90
|
8 score on a scale
Interval 5.0 to 10.0
|
8 score on a scale
Interval 5.0 to 10.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Day 120
|
8 score on a scale
Interval 4.0 to 10.0
|
8 score on a scale
Interval 4.0 to 10.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Day 180
|
8 score on a scale
Interval 5.0 to 10.0
|
8 score on a scale
Interval 5.0 to 10.0
|
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: Participants with time unwell.
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). Time unwell was the portion of follow-up (in days) that a participant was symptomatic, hospitalized, or deceased. The quantity is estimated from a Bayesian longitudinal ordinal regression model with covariate adjustment and weakly informative priors.
Outcome measures
| Measure |
Arm G - Metformin
n=1411 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1501 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Time Unwell in Days as Measured by the Symptom and Clinical Event Scale
|
11.55 days
Interval 11.41 to 11.67
|
11.51 days
Interval 11.38 to 11.65
|
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: Participants with time unwell.
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval.
Outcome measures
| Measure |
Arm G - Metformin
n=1411 Participants
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1501 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Mean Days Benefit as Measured by the Symptom and Clinical Event Scale
|
3.27 days
Interval 3.11 to 3.42
|
3.31 days
Interval 3.14 to 3.47
|
Adverse Events
Arm G - Metformin
Serious events: 7 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm G - Placebo
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm G - Metformin
n=1443 participants at risk
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1548 participants at risk
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Infections and infestations
Atypical pneumonia
|
0.07%
1/1443 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.00%
0/1548 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis due to human metapneumovirus
|
0.07%
1/1443 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.00%
0/1548 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Nervous system disorders
Encephalopathy acute
|
0.07%
1/1443 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.00%
0/1548 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Respiratory, thoracic and mediastinal disorders
Flu
|
0.07%
1/1443 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.00%
0/1548 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Metabolism and nutrition disorders
Iron deficiency anemia
|
0.07%
1/1443 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.00%
0/1548 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Vascular disorders
Myocardial Infarction
|
0.07%
1/1443 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.00%
0/1548 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Immune system disorders
Persistent asthma with acute exacerbation
|
0.00%
0/1443 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.06%
1/1548 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Infections and infestations
Pneumonia
|
0.07%
1/1443 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.00%
0/1548 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Nervous system disorders
Syncope
|
0.07%
1/1443 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.00%
0/1548 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/1443 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.06%
1/1548 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Renal and urinary disorders
Urinary Tract Infection bacterial
|
0.00%
0/1443 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.06%
1/1548 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
Other adverse events
| Measure |
Arm G - Metformin
n=1443 participants at risk
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
* 500 mg on Day 1;
* 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
* 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
|
Arm G - Placebo
n=1548 participants at risk
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.07%
1/1443 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.19%
3/1548 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.14%
2/1443 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.00%
0/1548 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Metabolism and nutrition disorders
Hypoglycaemic episode
|
0.00%
0/1443 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.06%
1/1548 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Metabolism and nutrition disorders
Hypoglycemia, unspecified
|
0.07%
1/1443 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.00%
0/1548 • Up to 180 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place