Trial Outcomes & Findings for Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer (NCT NCT02472353)
NCT ID: NCT02472353
Last Updated: 2019-10-16
Results Overview
Determine whether the addition of metformin to standard doxorubicin therapy in breast cancer patients will decrease the incidence of change in left ventricle ejection fraction (LVEF).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
1 year
Results posted on
2019-10-16
Participant Flow
Referrals and investigator's own patients
Participant milestones
| Measure |
Standard of Care
Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.
Doxorubicin: Standard of care treatment with doxorubicin
|
Metformin + Standard of Care
Patients will receive metformin during their treatment with doxorubicin for their breast cancer.
Metformin: Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.
Doxorubicin: Standard of care treatment with doxorubicin
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Standard of Care
Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.
Doxorubicin: Standard of care treatment with doxorubicin
|
Metformin + Standard of Care
Patients will receive metformin during their treatment with doxorubicin for their breast cancer.
Metformin: Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.
Doxorubicin: Standard of care treatment with doxorubicin
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Study Termination
|
1
|
4
|
Baseline Characteristics
Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer
Baseline characteristics by cohort
| Measure |
Standard of Care
n=14 Participants
Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.
Doxorubicin: Standard of care treatment with doxorubicin
|
Metformin + Standard of Care
n=16 Participants
Patients will receive metformin during their treatment with doxorubicin for their breast cancer.
Metformin: Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.
Doxorubicin: Standard of care treatment with doxorubicin
|
Total
n=30 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
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
43 years
n=5 Participants
|
53 years
n=7 Participants
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Echocardiography
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearDetermine whether the addition of metformin to standard doxorubicin therapy in breast cancer patients will decrease the incidence of change in left ventricle ejection fraction (LVEF).
Outcome measures
| Measure |
Standard of Care
n=10 Participants
Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.
Doxorubicin: Standard of care treatment with doxorubicin
|
Metformin + Standard of Care
n=10 Participants
Patients will receive metformin during their treatment with doxorubicin for their breast cancer.
Metformin: Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.
Doxorubicin: Standard of care treatment with doxorubicin
|
|---|---|---|
|
Number of Participants With Less Than or Equal to 5% Decrease in Left Ventricle Ejection Fraction (LVEF) on Echocardiogram
|
4 Participants
|
5 Participants
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Metformin + Standard of Care
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard of Care
n=14 participants at risk
Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.
Doxorubicin: Standard of care treatment with doxorubicin
|
Metformin + Standard of Care
n=16 participants at risk
Patients will receive metformin during their treatment with doxorubicin for their breast cancer.
Metformin: Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.
Doxorubicin: Standard of care treatment with doxorubicin
|
|---|---|---|
|
General disorders
Pain
|
0.00%
0/14 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
6.2%
1/16 • Number of events 1 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/14 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
12.5%
2/16 • Number of events 3 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Infections and infestations
Infection
|
0.00%
0/14 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
6.2%
1/16 • Number of events 1 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
Other adverse events
| Measure |
Standard of Care
n=14 participants at risk
Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.
Doxorubicin: Standard of care treatment with doxorubicin
|
Metformin + Standard of Care
n=16 participants at risk
Patients will receive metformin during their treatment with doxorubicin for their breast cancer.
Metformin: Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.
Doxorubicin: Standard of care treatment with doxorubicin
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
71.4%
10/14 • Number of events 17 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
87.5%
14/16 • Number of events 39 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
57.1%
8/14 • Number of events 10 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
43.8%
7/16 • Number of events 15 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
21.4%
3/14 • Number of events 3 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
31.2%
5/16 • Number of events 11 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Psychiatric disorders
Depression
|
21.4%
3/14 • Number of events 4 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
18.8%
3/16 • Number of events 4 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Eye disorders
Water Eyes
|
7.1%
1/14 • Number of events 1 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
12.5%
2/16 • Number of events 2 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Vascular disorders
Hot Flashes
|
50.0%
7/14 • Number of events 8 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
62.5%
10/16 • Number of events 28 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Gastrointestinal disorders
Diarrhea
|
57.1%
8/14 • Number of events 12 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
81.2%
13/16 • Number of events 26 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
21.4%
3/14 • Number of events 4 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
12.5%
2/16 • Number of events 2 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Investigations
Decreased Platelets
|
14.3%
2/14 • Number of events 2 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
12.5%
2/16 • Number of events 2 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Investigations
Decreased WBC
|
28.6%
4/14 • Number of events 4 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
37.5%
6/16 • Number of events 9 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
4/14 • Number of events 5 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
68.8%
11/16 • Number of events 22 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Investigations
Weight Loss
|
14.3%
2/14 • Number of events 2 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
25.0%
4/16 • Number of events 6 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Cardiac disorders
Tachycardia
|
7.1%
1/14 • Number of events 1 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
25.0%
4/16 • Number of events 6 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Gastrointestinal disorders
Constipation
|
50.0%
7/14 • Number of events 12 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
43.8%
7/16 • Number of events 13 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Psychiatric disorders
Anxiety
|
42.9%
6/14 • Number of events 6 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
56.2%
9/16 • Number of events 15 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Nervous system disorders
Headache
|
42.9%
6/14 • Number of events 10 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
56.2%
9/16 • Number of events 19 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
General disorders
Pain
|
64.3%
9/14 • Number of events 15 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
37.5%
6/16 • Number of events 7 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
General disorders
Fatigue
|
85.7%
12/14 • Number of events 20 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
100.0%
16/16 • Number of events 49 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Psychiatric disorders
Insomnia
|
64.3%
9/14 • Number of events 12 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
62.5%
10/16 • Number of events 28 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Nervous system disorders
Dysphagia
|
0.00%
0/14 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
12.5%
2/16 • Number of events 2 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
12.5%
2/16 • Number of events 2 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
35.7%
5/14 • Number of events 6 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
18.8%
3/16 • Number of events 3 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Investigations
Increased AST
|
7.1%
1/14 • Number of events 1 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
12.5%
2/16 • Number of events 2 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Infections and infestations
Sepsis
|
0.00%
0/14 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
12.5%
2/16 • Number of events 2 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
18.8%
3/16 • Number of events 3 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Nervous system disorders
Neuropathy
|
50.0%
7/14 • Number of events 9 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
25.0%
4/16 • Number of events 7 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.00%
0/14 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
18.8%
3/16 • Number of events 3 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
42.9%
6/14 • Number of events 8 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
18.8%
3/16 • Number of events 4 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.6%
4/14 • Number of events 7 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
31.2%
5/16 • Number of events 8 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
2/14 • Number of events 2 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
18.8%
3/16 • Number of events 4 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Vascular disorders
Hypertension
|
57.1%
8/14 • Number of events 14 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
56.2%
9/16 • Number of events 12 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Gastrointestinal disorders
Nausea
|
64.3%
9/14 • Number of events 16 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
75.0%
12/16 • Number of events 29 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Gastrointestinal disorders
Oral Mucositis
|
50.0%
7/14 • Number of events 7 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
43.8%
7/16 • Number of events 10 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
General disorders
Fever
|
7.1%
1/14 • Number of events 1 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
12.5%
2/16 • Number of events 2 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
57.1%
8/14 • Number of events 12 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
43.8%
7/16 • Number of events 12 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Investigations
Increased ALT
|
28.6%
4/14 • Number of events 4 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
18.8%
3/16 • Number of events 3 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Nervous system disorders
Dysgeusia
|
64.3%
9/14 • Number of events 11 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
43.8%
7/16 • Number of events 12 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Gastrointestinal disorders
Vomiting
|
21.4%
3/14 • Number of events 4 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
31.2%
5/16 • Number of events 6 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
General disorders
Edema
|
7.1%
1/14 • Number of events 1 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
31.2%
5/16 • Number of events 7 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Gastrointestinal disorders
Dyspnea
|
35.7%
5/14 • Number of events 6 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
12.5%
2/16 • Number of events 6 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
7.1%
1/14 • Number of events 1 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
12.5%
2/16 • Number of events 8 • Time point 1: Within 2 weeks of starting metformin Time point 2: 4 weeks after starting metformin Time point 3: 7 weeks after starting metformin Time point 4: 9 weeks after starting metformin (last assessment during treatment period)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place