Trial Outcomes & Findings for Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure (NCT NCT02653482)

NCT ID: NCT02653482

Last Updated: 2022-04-21

Results Overview

Difference in the average of the 6- and 12-week mean N-terminal pro B-type natriuretic peptide (NTproBNP).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

263 participants

Primary outcome timeframe

Average of Week 6 and Week 12

Results posted on

2022-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Dapagliflozin Dapagliflozin 10 mg daily Dapagliflozin	Dapagliflozin Matching Placebo Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo
Overall Study STARTED	131	132
Overall Study COMPLETED	130	131
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Dapagliflozin Dapagliflozin 10 mg daily Dapagliflozin	Dapagliflozin Matching Placebo Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo
Overall Study Death	1	1

Baseline Characteristics

Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dapagliflozin n=131 Participants Dapagliflozin 10 mg daily Dapagliflozin	Dapagliflozin Matching Placebo n=132 Participants Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo	Total n=263 Participants Total of all reporting groups
Age, Continuous	62.2 years STANDARD_DEVIATION 11.0 • n=5 Participants	60.4 years STANDARD_DEVIATION 12.0 • n=7 Participants	61.3 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	34 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	95 Participants n=5 Participants	98 Participants n=7 Participants	193 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	47 Participants n=5 Participants	52 Participants n=7 Participants	99 Participants n=5 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	70 Participants n=7 Participants	144 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	131 participants n=5 Participants	132 participants n=7 Participants	263 participants n=5 Participants
Duration of Heart Failure	7.1 years STANDARD_DEVIATION 5.8 • n=5 Participants	7.2 years STANDARD_DEVIATION 6.8 • n=7 Participants	7.1 years STANDARD_DEVIATION 6.3 • n=5 Participants
Previous Hospitalization for Heart Failure	101 Participants n=5 Participants	108 Participants n=7 Participants	209 Participants n=5 Participants
Time since last hospitalization for heart failure	1.4 years STANDARD_DEVIATION 2.3 • n=5 Participants	1.8 years STANDARD_DEVIATION 3.1 • n=7 Participants	1.6 years STANDARD_DEVIATION 2.7 • n=5 Participants
Ejection fraction	27.2 % STANDARD_DEVIATION 8.0 • n=5 Participants	25.7 % STANDARD_DEVIATION 8.2 • n=7 Participants	26.4 % STANDARD_DEVIATION 8.1 • n=5 Participants
Ischemic heart disease	70 Participants n=5 Participants	69 Participants n=7 Participants	139 Participants n=5 Participants
Type 2 diabetes mellitus	81 Participants n=5 Participants	85 Participants n=7 Participants	166 Participants n=5 Participants
Atrial Fibrillation	57 Participants n=5 Participants	49 Participants n=7 Participants	106 Participants n=5 Participants
Internal Cardiac Defibrillator (ICD)	88 Participants n=5 Participants	75 Participants n=7 Participants	163 Participants n=5 Participants
Cardiac resynchronization therapy (CRT)	43 Participants n=5 Participants	25 Participants n=7 Participants	68 Participants n=5 Participants
Angiotensin converting enzyme inhibitor (ACEI) / Angiotensin II receptor blocker (ARB)	76 Participants n=5 Participants	80 Participants n=7 Participants	156 Participants n=5 Participants
Angiotensin receptor-neprilysin inhibitor (ARNI)	47 Participants n=5 Participants	38 Participants n=7 Participants	85 Participants n=5 Participants
β-blockers	130 Participants n=5 Participants	124 Participants n=7 Participants	254 Participants n=5 Participants
Hydralazine	19 Participants n=5 Participants	26 Participants n=7 Participants	45 Participants n=5 Participants
Long-acting nitrates	17 Participants n=5 Participants	22 Participants n=7 Participants	39 Participants n=5 Participants
Mineralocorticoid receptor agonist (MRA)	76 Participants n=5 Participants	84 Participants n=7 Participants	160 Participants n=5 Participants
Loop diuretics	114 Participants n=5 Participants	111 Participants n=7 Participants	225 Participants n=5 Participants
Digoxin	25 Participants n=5 Participants	21 Participants n=7 Participants	46 Participants n=5 Participants
Lipid-lowering agents	107 Participants n=5 Participants	104 Participants n=7 Participants	211 Participants n=5 Participants
Anticoagulant agent	58 Participants n=5 Participants	42 Participants n=7 Participants	100 Participants n=5 Participants
Insulin - among patients with type 2 diabetes	42 Participants n=5 Participants	45 Participants n=7 Participants	87 Participants n=5 Participants
Glucagon-like peptide-1 receptor agonist (GLP-1RA ) - among patients with type 2 diabetes	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Dipeptidyl Pepdidase 4 (DPP4) inhibitor - among patients with type 2 diabetes	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sulfonylurea - among patients with type 2 diabetes	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Metformin - among patients with type 2 diabetes	29 Participants n=5 Participants	33 Participants n=7 Participants	62 Participants n=5 Participants
Body mass index	30.7 kg/m^2 n=5 Participants	30.6 kg/m^2 n=7 Participants	30.6 kg/m^2 n=5 Participants
Heart rate	72.2 beats per minute STANDARD_DEVIATION 12.4 • n=5 Participants	71.8 beats per minute STANDARD_DEVIATION 11.3 • n=7 Participants	71.9 beats per minute STANDARD_DEVIATION 12.3 • n=5 Participants
Systolic Blood Pressure	122.3 mm Hg STANDARD_DEVIATION 20.1 • n=5 Participants	124.8 mm Hg STANDARD_DEVIATION 21.6 • n=7 Participants	123.7 mm Hg STANDARD_DEVIATION 20.2 • n=5 Participants
N-terminal pro B-type natriuretic peptide (NT-proBNP)	1136 pg/mL n=5 Participants	1136 pg/mL n=7 Participants	1136 pg/mL n=5 Participants
Brain natriuretic peptide (BNP)	288 pg/mL n=5 Participants	242 pg/mL n=7 Participants	269 pg/mL n=5 Participants
Estimated glomerular filtration rate (eGFR)	66.9 mL/min/1.73m2 STANDARD_DEVIATION 21.1 • n=5 Participants	71.2 mL/min/1.73m2 STANDARD_DEVIATION 23.1 • n=7 Participants	69.1 mL/min/1.73m2 STANDARD_DEVIATION 22.2 • n=5 Participants
Urine Albumin/Creatinine Ratio	19.0 mg/g n=5 Participants	25.0 mg/g n=7 Participants	22.0 mg/g n=5 Participants
Hemoglobin A1c	7.0 % STANDARD_DEVIATION 1.8 • n=5 Participants	7.3 % STANDARD_DEVIATION 2.0 • n=7 Participants	7.2 % STANDARD_DEVIATION 1.9 • n=5 Participants
Hemoglobin	13.5 g/dL STANDARD_DEVIATION 1.9 • n=5 Participants	13.3 g/dL STANDARD_DEVIATION 1.7 • n=7 Participants	13.4 g/dL STANDARD_DEVIATION 1.8 • n=5 Participants
New York Heart Association (NYHA) Class II	91 Participants n=5 Participants	82 Participants n=7 Participants	173 Participants n=5 Participants
New York Heart Association (NYHA) Class III	40 Participants n=5 Participants	50 Participants n=7 Participants	90 Participants n=5 Participants
Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS)	67.4 score on a scale STANDARD_DEVIATION 22.0 • n=5 Participants	67.0 score on a scale STANDARD_DEVIATION 21.1 • n=7 Participants	67.2 score on a scale STANDARD_DEVIATION 21.5 • n=5 Participants
Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CS)	70.8 score on a scale STANDARD_DEVIATION 21.9 • n=5 Participants	69.9 score on a scale STANDARD_DEVIATION 21.4 • n=7 Participants	70.3 score on a scale STANDARD_DEVIATION 21.6 • n=5 Participants
6-minute walk distance	306 meters n=5 Participants	305 meters n=7 Participants	305 meters n=5 Participants

PRIMARY outcome

Timeframe: Average of Week 6 and 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.

Difference in the average of the 6- and 12-week mean N-terminal pro B-type natriuretic peptide (NTproBNP).

Outcome measures

Outcome measures
Measure	Dapagliflozin n=130 Participants Dapagliflozin 10 mg daily Dapagliflozin	Dapagliflozin Matching Placebo n=129 Participants Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo
Difference in the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP).	1133 pg/dL Interval 1036.0 to 1238.0	1191 pg/dL Interval 1089.0 to 1304.0

PRIMARY outcome

Timeframe: Average of Week 6 and 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.

A composite of the percentage of patients that achieved a meaningful improvement in health status (≥5-point increase in average of 6- and 12-week KCCQ-OS) or NT-proBNP (≥20% decrease in average of 6- and 12-week NT-proBNP). 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 overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points.

Outcome measures

Outcome measures
Measure	Dapagliflozin n=130 Participants Dapagliflozin 10 mg daily Dapagliflozin	Dapagliflozin Matching Placebo n=129 Participants Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo
Percentage of Patients That Achieve a ≥ 5-point Increase in Heart Failure Disease Specific Quality of Life (Assessed Using Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)) or a ≥ 20% Decrease in NTproBNP Over 12 Weeks	61.5 % of participants	50.4 % of participants

SECONDARY outcome

Timeframe: Baseline to Week 6 and 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.

Percentage of patients with a ≥ 5-point increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) as measured at Week 6 and 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 overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points.

Outcome measures

Outcome measures
Measure	Dapagliflozin n=130 Participants Dapagliflozin 10 mg daily Dapagliflozin	Dapagliflozin Matching Placebo n=129 Participants Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo
Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Week 6 - Improvement in KCCQ-OS	59 Participants	46 Participants
Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Week 12 - Improvement in KCCQ-OS	54 Participants	41 Participants

SECONDARY outcome

Timeframe: Baseline to Week 6 and 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.

Percentage of patients with a ≥ 20% decrease in NTproBNP as measured at Week 6 and Week 12.

Outcome measures

Outcome measures
Measure	Dapagliflozin n=130 Participants Dapagliflozin 10 mg daily Dapagliflozin	Dapagliflozin Matching Placebo n=129 Participants Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo
Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP) NTproBNP decrease ≥ 20 % at Week 6	43 Participants	42 Participants
Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP) NTproBNP decrease ≥ 20 % at Week 12	55 Participants	37 Participants

SECONDARY outcome

Timeframe: Average of Week 6 and 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.

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 overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points.

Outcome measures

Outcome measures
Measure	Dapagliflozin n=130 Participants Dapagliflozin 10 mg daily Dapagliflozin	Dapagliflozin Matching Placebo n=129 Participants Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo
Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS) and a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)	20 Participants	17 Participants

SECONDARY outcome

Timeframe: Baseline to Week 6 and 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.

Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) over 12 weeks as measured at Week 6 and 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 overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points.

Outcome measures

Outcome measures
Measure	Dapagliflozin n=130 Participants Dapagliflozin 10 mg daily Dapagliflozin	Dapagliflozin Matching Placebo n=129 Participants Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks. KCCQ-OS - week 6	71.1 score on a scale Interval 68.7 to 73.5	70.1 score on a scale Interval 67.7 to 72.5
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks. KCCQ-OS - week 12	72.6 score on a scale Interval 70.2 to 75.0	68.9 score on a scale Interval 66.5 to 71.4

SECONDARY outcome

Timeframe: Baseline to Week 6 and 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.

Change in 6 minute walk score over 12 weeks as measured at Week 6 and Week 12. The 6 minute walk test measures the distance in meters that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.

Outcome measures

Outcome measures
Measure	Dapagliflozin n=130 Participants Dapagliflozin 10 mg daily Dapagliflozin	Dapagliflozin Matching Placebo n=129 Participants Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo
Change in 6 Minute Walk Score Over 12 Weeks. 6-minute walk distance - 6 weeks	297.1 meters Interval 285.1 to 309.6	289.6 meters Interval 278.0 to 301.7
Change in 6 Minute Walk Score Over 12 Weeks. 6-minute walk distance - 12 weeks	303.7 meters Interval 291.2 to 316.7	301.3 meters Interval 289.1 to 313.9

SECONDARY outcome

Timeframe: Baseline to Week 6 and 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.

Change in BNP over 12 weeks as measured at Week 6 and Week 12 as measured at Week 6 and Week 12.

Outcome measures

Outcome measures
Measure	Dapagliflozin n=130 Participants Dapagliflozin 10 mg daily Dapagliflozin	Dapagliflozin Matching Placebo n=129 Participants Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo
Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks. BNP - week 6	236 pg/mL Interval 212.0 to 263.0	265 pg/mL Interval 238.0 to 296.0
Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks. BNP - week 12	228 pg/mL Interval 204.0 to 254.0	272 pg/mL Interval 243.0 to 303.0

SECONDARY outcome

Timeframe: Baseline to Week 6 and Week 12

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

Change in HbA1c over 12 weeks as measured at Week 6 and Week 12.

Outcome measures

Outcome measures
Measure	Dapagliflozin n=130 Participants Dapagliflozin 10 mg daily Dapagliflozin	Dapagliflozin Matching Placebo n=129 Participants Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo
Change in Hemoglobin A1c (HbA1c) Over 12 Weeks. HbA1c - week 6	6.9 percentage of glycated hemoglobin Interval 6.8 to 7.1	7.1 percentage of glycated hemoglobin Interval 7.0 to 7.2
Change in Hemoglobin A1c (HbA1c) Over 12 Weeks. HbA1c - week 12	6.9 percentage of glycated hemoglobin Interval 6.8 to 7.1	7.1 percentage of glycated hemoglobin Interval 7.0 to 7.2

SECONDARY outcome

Timeframe: Baseline to Week 6 and 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.

Change in weight over 12 weeks as measured at Week 6 and Week 12.

Outcome measures

Outcome measures
Measure	Dapagliflozin n=130 Participants Dapagliflozin 10 mg daily Dapagliflozin	Dapagliflozin Matching Placebo n=129 Participants Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo
Change in Weight Over 12 Weeks Weight - week 6	96.0 kg Interval 95.4 to 96.5	96.6 kg Interval 96.0 to 97.1
Change in Weight Over 12 Weeks Weight - week 12	96.3 kg Interval 95.7 to 96.8	96.6 kg Interval 96.0 to 97.1

SECONDARY outcome

Timeframe: Baseline to Week 6 and 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.

Change in systolic blood pressure over 12 weeks as measured at Week 6 and Week 12.

Outcome measures

Outcome measures
Measure	Dapagliflozin n=130 Participants Dapagliflozin 10 mg daily Dapagliflozin	Dapagliflozin Matching Placebo n=129 Participants Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo
Change in Systolic Blood Pressure Over 12 Weeks Systolic Blood Pressure - week 6	119.2 mm Hg Interval 116.6 to 121.9	121.1 mm Hg Interval 118.5 to 122.4
Change in Systolic Blood Pressure Over 12 Weeks Systolic Blood Pressure - week 12	120.9 mm Hg Interval 118.2 to 123.5	119.8 mm Hg Interval 117.2 to 122.4

Adverse Events

Dapagliflozin

Serious events: 32 serious events

Other events: 19 other events

Deaths: 1 deaths

Dapagliflozin Matching Placebo

Serious events: 31 serious events

Other events: 18 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Dapagliflozin n=131 participants at risk Dapagliflozin 10 mg daily Dapagliflozin	Dapagliflozin Matching Placebo n=132 participants at risk Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo
Cardiac disorders Urgent Heart Failure Visit	2.3% 3/131 • 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.	5.3% 7/132 • Number of events 12 • 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	7.6% 10/131 • Number of events 12 • 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.	5.3% 7/132 • 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.
Endocrine disorders Severe Hypoglycemia	0.76% 1/131 • 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.	0.76% 1/132 • 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	1.5% 2/131 • 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.	0.76% 1/132 • 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.
Skin and subcutaneous tissue disorders Rash	0.00% 0/131 • 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.	0.76% 1/132 • 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 Syncope	0.76% 1/131 • 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% 0/132 • 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 Tract Infection	0.76% 1/131 • 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% 0/132 • 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 Vaginal Discharge	0.76% 1/131 • 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% 0/132 • 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.
Skin and subcutaneous tissue disorders Bullae	0.00% 0/131 • 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.	1.5% 2/132 • 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 Atypical Chest Pain	0.00% 0/131 • 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.	0.76% 1/132 • 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 Headache	0.76% 1/131 • 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% 0/132 • 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

Program Manager, Cardiometabolic Research

Saint Luke's Hospital of Kansas City

Phone: 8166957561

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60