Trial Outcomes & Findings for Dapagliflozin in PRESERVED Ejection Fraction Heart Failure (NCT NCT03030235)

NCT ID: NCT03030235

Last Updated: 2022-10-19

Results Overview

Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CS) at Week 12. The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-CS, a small but clinically meaningful change is considered to be ≥ 5 points. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 324 participants
• Primary outcome timeframe: Baseline to Week 12
• Results posted on: 2022-10-19

Participant Flow

Participant milestones

Measure	Dapagliflozin Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet	Placebo Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo
Overall Study STARTED	162	162
Overall Study COMPLETED	146	145
Overall Study NOT COMPLETED	16	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with a history of atrial fibrillation.

Baseline characteristics by cohort

Measure	Dapagliflozin n=162 Participants Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet	Placebo n=162 Participants Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo	Total n=324 Participants Total of all reporting groups
Age, Continuous	69 years n=162 Participants	71 years n=162 Participants	70 years n=324 Participants
Sex: Female, Male Female	92 Participants n=162 Participants	92 Participants n=162 Participants	184 Participants n=324 Participants
Sex: Female, Male Male	70 Participants n=162 Participants	70 Participants n=162 Participants	140 Participants n=324 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=162 Participants	1 Participants n=162 Participants	1 Participants n=324 Participants
Race (NIH/OMB) Asian	3 Participants n=162 Participants	0 Participants n=162 Participants	3 Participants n=324 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=162 Participants	1 Participants n=162 Participants	1 Participants n=324 Participants
Race (NIH/OMB) Black or African American	50 Participants n=162 Participants	47 Participants n=162 Participants	97 Participants n=324 Participants
Race (NIH/OMB) White	108 Participants n=162 Participants	107 Participants n=162 Participants	215 Participants n=324 Participants
Race (NIH/OMB) More than one race	0 Participants n=162 Participants	2 Participants n=162 Participants	2 Participants n=324 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=162 Participants	4 Participants n=162 Participants	5 Participants n=324 Participants
Region of Enrollment United States	162 participants n=162 Participants	162 participants n=162 Participants	324 participants n=324 Participants
Duration of Heart Failure	3.0 years n=162 Participants	3.2 years n=162 Participants	3.0 years n=324 Participants
Previous Hospitalization for Heart Failure	98 Participants n=162 Participants	83 Participants n=162 Participants	181 Participants n=324 Participants
Ejection Fraction	60 percent n=162 Participants	60 percent n=162 Participants	60 percent n=324 Participants
Ischemic Heart Disease	32 Participants n=162 Participants	31 Participants n=162 Participants	63 Participants n=324 Participants
Type 2 Diabetes	90 Participants n=162 Participants	91 Participants n=162 Participants	181 Participants n=324 Participants
Atrial Fibrillation	82 Participants n=162 Participants	89 Participants n=162 Participants	171 Participants n=324 Participants
Internal Cardiac Defibrillator (ICD)	7 Participants n=162 Participants	9 Participants n=162 Participants	16 Participants n=324 Participants
Angiotensin converting enzyme inhibitor (ACEI) / Angiotensin II receptor blocker (ARB)	98 Participants n=162 Participants	98 Participants n=162 Participants	196 Participants n=324 Participants
Angiotensin receptor-neprilysin inhibitor (ARNI)	2 Participants n=162 Participants	3 Participants n=162 Participants	5 Participants n=324 Participants
Beta-blockers	119 Participants n=162 Participants	116 Participants n=162 Participants	235 Participants n=324 Participants
Hydralazine	25 Participants n=162 Participants	18 Participants n=162 Participants	43 Participants n=324 Participants
Long-Acting Nitrates	34 Participants n=162 Participants	27 Participants n=162 Participants	61 Participants n=324 Participants
Mineralocorticoid receptor agonist (MRA)	50 Participants n=162 Participants	68 Participants n=162 Participants	118 Participants n=324 Participants
Loop Diuretics	151 Participants n=162 Participants	135 Participants n=162 Participants	286 Participants n=324 Participants
Lipid-Lowering Agents	132 Participants n=162 Participants	127 Participants n=162 Participants	259 Participants n=324 Participants
Anticoagulant Agents	71 Participants n=162 Participants	84 Participants n=162 Participants	155 Participants n=324 Participants
Body Mass Index (BMI)	35.1 kg/m^2 n=162 Participants	34.6 kg/m^2 n=162 Participants	34.7 kg/m^2 n=324 Participants
Heart Rate	70 beats per minute n=162 Participants	68 beats per minute n=162 Participants	68 beats per minute n=324 Participants
Systolic Blood Pressure	134 mm Hg n=162 Participants	132 mm Hg n=162 Participants	133 mm Hg n=324 Participants
N-terminal pro B-type natriuretic peptide (NT-proBNP) - overall	641 pg/mL n=162 Participants	710 pg/mL n=162 Participants	671 pg/mL n=324 Participants
N-terminal pro B-type natriuretic peptide (NT-proBNP) - participants with atrial fibrillation	830 pg/mL n=82 Participants • The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with a history of atrial fibrillation.	816 pg/mL n=89 Participants • The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with a history of atrial fibrillation.	816 pg/mL n=171 Participants • The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with a history of atrial fibrillation.
N-terminal pro B-type natriuretic peptide (NT-proBNP) - participants with no atrial fibrillation	438 pg/mL n=80 Participants • The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with no history of atrial fibrillation.	485 pg/mL n=73 Participants • The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with no history of atrial fibrillation.	459 pg/mL n=153 Participants • The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with no history of atrial fibrillation.
Brain Natriuretic Peptide (BNP) - overall	137 pg/mL n=162 Participants	151 pg/mL n=162 Participants	142 pg/mL n=324 Participants
Brain Natriuretic Peptide (BNP) - participants with atrial fibrillation	169 pg/mL n=82 Participants • The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with a history of atrial fibrillation.	151 pg/mL n=89 Participants • The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with a history of atrial fibrillation.	154 pg/mL n=171 Participants • The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with a history of atrial fibrillation.
Brain Natriuretic Peptide (BNP) - participants with no atrial fibrillation	107 pg/mL n=80 Participants • The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with no history of atrial fibrillation.	161 pg/mL n=73 Participants • The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with no history of atrial fibrillation.	128 pg/mL n=153 Participants • The number of participants analyzed differs from the overall number of participants analyzed as this analysis has been completed only in participants with no history of atrial fibrillation.
Estimated glomerular filtration rate (eGFR)	56 mL/minute n=162 Participants	54 mL/minute n=162 Participants	55 mL/minute n=324 Participants
Hemoglobin A1c	6.0 percent of glycosylated hemoglobin n=162 Participants	6.2 percent of glycosylated hemoglobin n=162 Participants	6.1 percent of glycosylated hemoglobin n=324 Participants
Hemoglobin	12.7 g/dL n=162 Participants	12.6 g/dL n=162 Participants	12.6 g/dL n=324 Participants
New York Heart Association (NYHA) Class II	96 Participants n=162 Participants	90 Participants n=162 Participants	186 Participants n=324 Participants
New York Heart Association (NYHA) Class III/IV	65 Participants n=162 Participants	72 Participants n=162 Participants	137 Participants n=324 Participants
Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS)	63.2 units on a scale STANDARD_DEVIATION 20.4 • n=162 Participants	62.3 units on a scale STANDARD_DEVIATION 20.6 • n=162 Participants	62.7 units on a scale STANDARD_DEVIATION 20.4 • n=324 Participants
Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CS)	63.4 units on a scale STANDARD_DEVIATION 19.7 • n=162 Participants	61.8 units on a scale STANDARD_DEVIATION 20.3 • n=162 Participants	62.6 units on a scale STANDARD_DEVIATION 20.0 • n=324 Participants
6 minute walk test	244 meters n=162 Participants	244 meters n=162 Participants	244 meters n=324 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CS) at Week 12.

The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-CS, a small but clinically meaningful change is considered to be ≥ 5 points.

Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Outcome measures

Measure	Dapagliflozin n=162 Participants Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet	Placebo n=162 Participants Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo
Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Summary Score (KCCQ-CS)	68.6 score on a scale Interval 66.2 to 71.0	62.8 score on a scale Interval 60.4 to 65.3

SECONDARY outcome

Timeframe: Baseline to Week 12

Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) at Week 12.

The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.

Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Outcome measures

Measure	Dapagliflozin n=162 Participants Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet	Placebo n=162 Participants Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo
Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)	68.9 score on a scale Interval 66.5 to 71.3	64.5 score on a scale Interval 62.1 to 66.8

SECONDARY outcome

Timeframe: Baseline to Week 12

NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Outcome measures

Measure	Dapagliflozin n=162 Participants Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet	Placebo n=162 Participants Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo
Effect of Dapagliflozin, as Compared With Placebo, on N-terminal Pro B-type Natriuretic Peptide (NTproBNP)	733 pg/mL Interval 673.0 to 799.0	739 pg/mL Interval 678.0 to 805.0

SECONDARY outcome

Timeframe: Baseline to Week 12

BNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Outcome measures

Measure	Dapagliflozin n=162 Participants Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet	Placebo n=162 Participants Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo
Effect of Dapagliflozin, as Compared With Placebo, on Brain Natriuretic Peptide (BNP)	147 pg/mL Interval 136.0 to 160.0	147 pg/mL Interval 136.0 to 160.0

SECONDARY outcome

Timeframe: Baseline to Week 12

6 minute walk test distance at 12 weeks. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Outcome measures

Measure	Dapagliflozin n=162 Participants Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet	Placebo n=162 Participants Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo
Effect of Dapagliflozin, as Compared With Placebo, on 6 Minute Walk Test Distance	262 meters Interval 252.0 to 272.0	242 meters Interval 232.0 to 252.0

SECONDARY outcome

Timeframe: Baseline to Week 12

Hemoglobin A1c at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Outcome measures

Measure	Dapagliflozin n=162 Participants Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet	Placebo n=162 Participants Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo
Effect of Dapagliflozin, as Compared With Placebo, on Hemoglobin A1c	6.5 Percent Interval 6.4 to 6.6	6.6 Percent Interval 6.5 to 6.7

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: The number of participants analyzed may differ from the overall number of participants analyzed due to missing data at certain timepoints for some participants.

Proportion of patients with a ≥ 5 point increase in KCCQ-CS and KCCQ-OS at Week 12.

The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For KCCQ-CS and KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.

Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Outcome measures

Measure	Dapagliflozin n=152 Participants Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet	Placebo n=152 Participants Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo
Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 5 Point Increase in KCCQ Clinical Summary Score (KCCQ-CS) and KCCQ Overall Summary Score (KCCQ-OS) KCCQ-CS increase ≥ 5 points	69 Participants	53 Participants
Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 5 Point Increase in KCCQ Clinical Summary Score (KCCQ-CS) and KCCQ Overall Summary Score (KCCQ-OS) KCCQ-OS increase ≥ 5 points	75 Participants	58 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: The number of participants analyzed may differ from the overall number of participants analyzed due to missing data at certain timepoints for some participants.

Proportion of patients with a ≥ 20% decrease in NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Outcome measures

Measure	Dapagliflozin n=150 Participants Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet	Placebo n=150 Participants Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo
Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)	48 Participants	44 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: The number of participants analyzed may differ from the overall number of participants analyzed due to missing data at certain timepoints for some participants.

Proportion of patients with a ≥ 5 point increase in KCCQ-CS and a ≥ 20% decrease in NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Outcome measures

Measure	Dapagliflozin n=148 Participants Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet	Placebo n=150 Participants Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo
Effect of Dapagliflozin, as Compared With Placebo, on Proportion of Patients With ≥ 5 Point Increase in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) and ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide(NTproBNP)	23 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Weight at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Outcome measures

Measure	Dapagliflozin n=162 Participants Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet	Placebo n=162 Participants Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo
Effect of Dapagliflozin, as Compared With Placebo, on Weight	101.3 kilograms Interval 100.9 to 101.8	102.1 kilograms Interval 101.6 to 102.6

SECONDARY outcome

Timeframe: Baseline to Week 12

Systolic blood pressure at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Outcome measures

Measure	Dapagliflozin n=162 Participants Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet	Placebo n=162 Participants Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo
Effect of Dapagliflozin, as Compared With Placebo, on Systolic Blood Pressure	133 mm Hg Interval 130.0 to 135.0	133 mm Hg Interval 131.0 to 136.0

Adverse Events

Dapagliflozin

Serious events: 31 serious events

Other events: 13 other events

Deaths: 1 deaths

Placebo

Serious events: 22 serious events

Other events: 16 other events

Deaths: 2 deaths

Serious adverse events

Measure	Dapagliflozin n=162 participants at risk Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet	Placebo n=162 participants at risk Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo
Injury, poisoning and procedural complications Abdominal Wall Hematoma	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Acute Kidney Injury	4.9% 8/162 • Number of events 8 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	2.5% 4/162 • Number of events 4 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Acute Renal Failure	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Acute Respiratory Distress	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Acute Right Cerebellar Infarct	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Blood and lymphatic system disorders Anemia	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Hepatobiliary disorders Ascites of the Abdomen	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Cardiac disorders Atrial Fibrillation	1.9% 3/162 • Number of events 3 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Cardiac disorders Atrial Flutter	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Benign Paroxysmal Positional Vertigo	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Infections and infestations Cellulitis	1.2% 2/162 • Number of events 2 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	1.9% 3/162 • Number of events 3 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Chest Pain	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	1.2% 2/162 • Number of events 2 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Infections and infestations Clostridium Difficile	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Infections and infestations Covid-19	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	1.2% 2/162 • Number of events 2 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Critical Limb Ischemia	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Gastrointestinal disorders Diarrhea	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Gastrointestinal disorders Diverticulitis	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Cardiac disorders Elective Watchman Device Implantation	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Elevated Troponin in the setting of Covid-19	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Exacerbation of Chronic Obstructive Pulmonary Disease	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Cardiac disorders Exacerbation of Heart Failure	8.6% 14/162 • Number of events 17 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	3.7% 6/162 • Number of events 7 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Eye disorders Gastroenteritis	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Gastrointestinal disorders Gastrointestinal bleed	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Hematuria	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Hemochromatosis	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Hemoptysis	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Hypercapnic and hypoxic respiratory failure requiring intubation	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Hyperglycemia	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Hypotension	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Infections and infestations Infected right great toe	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Infections and infestations Influenza A	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Cardiac disorders Iron Overload cardiomyopathy	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Left hilar mass	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Injury, poisoning and procedural complications Left hip fracture	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Hepatobiliary disorders Liver failure/Cirrhosis leading to Hepatic/Metabolic Encephalopathy	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Melena and hematochezia	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Infections and infestations Multiple Abscesses	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Non cardiac chest pain	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Musculoskeletal and connective tissue disorders Osteoarthritis (Right Hip)	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Musculoskeletal and connective tissue disorders Osteomyelitis (left foot)	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Gastrointestinal disorders Pancreatitis	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Infections and infestations Parainfluenza	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Cardiac disorders Aortic Ulcer	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Infections and infestations Pneumonia	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Renal failure leading to endstage renal disease requiring dialysis	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Musculoskeletal and connective tissue disorders Right leg pain	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Infections and infestations Right Shoulder - Infected Arthroplasty	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Infections and infestations Salmonella enteritis/diverticulitis	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Schwannoma of spinal cord at L1-L2	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Infections and infestations Sepsis	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	1.2% 2/162 • Number of events 2 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Infections and infestations Septic Arthritis of the Right Knee	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Infections and infestations Septicemia	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Endstage chronic obstructive pulmonary disease with hypoxic and hypercapnic respiratory failure	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Suicidal Ideation	1.2% 2/162 • Number of events 2 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Syncope	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Cardiac disorders Type II NSTEMI	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Uncontrolled Hypertension	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Infections and infestations Upper Respiratory Infection	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Cardiac disorders Ventricular Tachycardia	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Volume Depletion	1.2% 2/162 • Number of events 2 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 2 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Hypertensive Crisis	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Musculoskeletal and connective tissue disorders Worsening Osteoarthritis - Left Knee	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.

Other adverse events

Measure	Dapagliflozin n=162 participants at risk Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks Dapagliflozin 10Mg Oral Tablet: Dapagliflozin 10Mg Oral Tablet	Placebo n=162 participants at risk Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks Dapagliflozin matching placebo: Dapagliflozin matching placebo
General disorders Volume Depletion	6.2% 10/162 • Number of events 11 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	4.3% 7/162 • Number of events 7 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Cardiac disorders Urgent Heart Failure Visit	4.9% 8/162 • Number of events 8 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	4.9% 8/162 • Number of events 13 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Nausea	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Musculoskeletal and connective tissue disorders Leg pain	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Musculoskeletal and connective tissue disorders Back Pain	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Fatigue	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Musculoskeletal and connective tissue disorders Neck Pain	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Infections and infestations Urinary Tract Infection	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
Gastrointestinal disorders Gastrointestinal intolerance	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Urinary frequency	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Rash	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Blurry vision	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Chest pain	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Shortness of Breath	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Foul smelling urine	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.
General disorders Sense of hopelessness	0.62% 1/162 • Number of events 1 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.	0.00% 0/162 • Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period. Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and lower limb amputations.

Additional Information

PRESERVED-HF Study Manager

Saint Luke's Hospital of Kansas City

Phone: 816-932-9858

Email: PRESERVED-HF@saint-lukes.org

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor will have 18 months after the study closure to arrange for the submission of multicenter publications. If multicenter publications are not submitted within 24 months after conclusion of the study, PI may publish the results from their site's data, pursuant to approval by the Sponsor and Executive Committee at least 60 days prior to submission. The Sponsor cannot require changes to the communication with the exception of requiring the removal of confidential information.
• Publication restrictions are in place

Restriction type: OTHER