Diabetes, Heart Failure
Conditions
Keywords
hospitalization, mortality, time of initiation of therapy, quality of life, cost-effectiveness, dapagliflozin, clinical trial, diabetes
Brief summary
This study will evaluate the safety and efficacy of dapagliflozin treatment in preventing hospital re-admissions, emergency room (ER) visits, urgent clinic visits, and death in patients with and without type 2 diabetes (T2D) after hospital admission for heart failure.
Detailed description
The prevalence of both heart failure and type 2 diabetes (T2D) or prediabetes are reaching epidemic proportions globally and in the United States. More than 40% of patients with established heart failure (HF) have diabetes. Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor (SGLT2-i) indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D mellitus. Treatment with SGLT2-i has been shown to reduce both heart failure hospitalizations and mortality in patients with established heart disease. However, the time of initiation of SGLT2-i therapy has not been evaluated in patients with HF. This study will be the first trial to evaluate the safety and efficacy of dapagliflozin treatment in preventing hospital re-admissions, ER visits, urgent clinic visits, and death in patients with and without T2D after hospital admission for heart failure. In addition, the impact of treatment on HF symptoms quality of life, resource utilization, and cost-effectiveness of dapagliflozin versus placebo will be evaluated. The results of this study have great potential to impact and facilitate care and to change current clinical guidelines in the management of patients with heart failure. Patients with and without diabetes who have acute decompensated heart failure (ADHF) will be randomized to take either dapagliflozin or placebo daily for 26 weeks, beginning at the time of discharge from from the hospital.
Interventions
DRUGDapagliflozin
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Participants will receive 10 mg/day of dapagliflozin, beginning at hospital discharge, for 26 weeks.
DRUGPlacebo
Participants will receive a placebo to match 10 mg/day of dapagliflozin, beginning at hospital discharge, for 26 weeks.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females between the ages of 18 and 90 years, with ADHF, and New York Heart Association (NYHA) class II, III, or IV symptoms discharged after hospital admission with a clinical diagnosis ADHF 2. Elevated natriuretic peptide tests measure levels of BNP (NT-pro-BNP) ≥300 pg/ml or B-type natriuretic peptide (BNP) ≥100 pg/ml on admission 3. Interpretable echocardiogram during hospital admission (or within 12 months prior to index hospitalization) 4. Blood glucose level \<400 mg/dL without evidence of diabetic ketoacidosis (serum bicarbonate \<18 milliequivalent (mEq)/L or positive serum or urinary ketones), in patients with T2D
Exclusion criteria
1. Age \< 18 or \> 90 years 2. Subjects with a history of type 1 diabetes 3. Treatment with thiazolidinediones (TZDs) or SGLT2-i during the past 3 months of admission 4. Recurrent episodes of severe hypoglycemia or hypoglycemic unawareness 5. History of recurrent HF admissions considered to be due to non-compliance (evaluated by the research staff for participation) 6. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 3 times upper limit of normal 7. Patients with impaired renal function (GFR \< 25 ml/min) 8. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study 9. Patients on ventricular assist devices (VADs) 10. History of heart transplant or listed for heart transplant 11. History of cardiac surgery (within 90 days prior to enrollment) or planned cardiac interventions within the following 6 months, including percutaneous coronary intervention (PCI), ablation, cardiac resynchronization therapy (CRT) implantable cardioverter-defibrillator (ICD) 12. HF due to restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valvular diseases, hypertrophic cardiomyopathy, or congenital heart disease 13. History of SGLT2-i allergy 14. Systolic blood pressure \< 100 mmHg 15. Uncontrolled hypertension, defined as a systolic blood pressure \> 200 mmHg at randomization 16. Female subjects who are pregnant or breast-feeding at time of enrollment into the study 17. Females of childbearing potential who are not using adequate contraceptive methods 18. In hospice or expected life expectancy less than 6 months 19. Patients with diabetic foot infection, osteomyelitis and history of amputation of lower extremities within 6 months of admission 20. Patients anticipated to undergo major surgical procedures during the following 6 months 21. Patients with active hematuria, urinary tract infection (UTI), or history of frequent UTIs or genital mycotic infections 22. Uncontrolled atrial fibrillation or atrial flutter with a resting heart rate \>110bpm documented by ECG at randomization 23. Any condition that in the opinion of the investigator would contraindicate the assessment of distance walked in 6 minutes (6MWD) 24. Chronic pulmonary disease, i.e. with known forced expiratory volume in the first second (FEV1) \<50% requiring home oxygen, or oral steroid therapy or current hospitalization for severe chronic obstructive pulmonary disease (COPD) thought to be a primary contributor to dyspnea, or significant chronic pulmonary disease in the Investigator's opinion, or primary pulmonary arterial hypertension 25. Patients with active history of bladder cancer 26. Patients with previous history of diabetic ketoacidosis, per American Diabetes Association (ADA) criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death | Up to 26 weeks | The number of participants meeting criteria for a composite of hospital admissions, emergency department visits, urgent clinic visits for heart failure and death after admission with acute decompensated heart failure (ADHF) was determined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score | Baseline, Week 12, Week 26 | Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) assesses patients' perception of their heart failure and measures the impact of heart failure symptoms. The CHQ-SAS contains 16 standardized questions that assess dyspnea during daily activities, fatigue and emotional function. Items are rated on a 7-point Likert scale ranging from 1 to 7. The total score is the mean of the item scores and higher scores indicate better quality of life. |
| N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels | Baseline, Week 12, Week 26 | The heart failure, disease-specific biomarker N-terminal (NT)-pro hormone BNP (NT-proBNP) is a non-active prohormone. Levels increase when heart failure develops or gets worse and levels reduce when heart failure is stable. |
| 6-Minute Walk Distance (6MWD) | Baseline, Week 12, Week 26 | The 6-Minute Walk Distance (6MWD) test measures the distance, in meters, that a patient can quickly walk on a flat, hard surface in a period of 6 minutes |
| Hemoglobin A1C (HbA1c) Level | Baseline, Week 12, Week 26 | HbA1c was quantified by blood test, in participants with type 2 diabetes (T2D). Higher percentages of glycated hemoglobin on red blood cells (RBCs) indicate higher blood glucose levels in the previous three months. A normal HbA1c level is below 5.7 percent. |
| Weight | Baseline,Week 12, Week 26 | Weight is measured in kilograms. |
| Systolic Blood Pressure | Baseline, Week 12, Week 26 | Systolic blood pressure is measured in millimeters of mercury (mmHg). A normal systolic blood pressure level is less than 120 mmHg. |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) Score | Baseline, Week 12, Week 26 | The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. |
| Serum Magnesium | Baseline, Week 12, Week 26 | Normal levels of serum magnesium are between 1.7 and 2.3 milligrams per deciliter (mg/dL). |
| Number of Participants Dying From Cardiovascular Reasons | Up to Week 26 | The number of participants dying due to cardiovascular reasons was documented. |
| Number of Participants With Non-fatal Myocardial Infarction (MI) | Up to Week 26 | The number of participants with non-fatal myocardial infarction (MI) was documented. |
| Number of Participants With Stroke | Up to Week 26 | The number of participants experiencing a stroke was documented. |
| Number of Participants With Acute Kidney Injury | Up to Week 26 | The number of participants experiencing acute kidney injury was documented. |
| Left Atrial Diameter | Baseline, Week 12, Week 26 | The normal range for left atrial diameter is 2.0 to 4.0 centimeters (cm). The left atrium increases in size with heart conditions. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from three sites in the USA: Emory University Hospital in Atlanta, Georgia, Tulane University in New Orleans, Louisiana, and Temple University in Philadelphia, Pennsylvania. Participant enrollment began July 29, 2020 and all follow-up assessments were completed by March 3, 2022.
Participants by arm
| Arm | Count |
|---|---|
| Dapagliflozin Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily. | 50 |
| Placebo Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily. | 55 |
| Total | 105 |
Baseline characteristics
| Characteristic | Dapagliflozin | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 45 Participants | 85 Participants |
| Age, Continuous | 56.12 years STANDARD_DEVIATION 13.47 | 55.49 years STANDARD_DEVIATION 11.63 | 55.79 years STANDARD_DEVIATION 12.48 |
| Diabetes Status Diabetic (Type 2 Diabetes) | 21 Participants | 17 Participants | 38 Participants |
| Diabetes Status Non-diabetic | 26 Participants | 31 Participants | 57 Participants |
| Diabetes Status Pre-diabetic | 3 Participants | 7 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 55 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants | 42 Participants | 80 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 8 Participants | 16 Participants |
| Region of Enrollment United States | 50 Participants | 55 Participants | 105 Participants |
| Sex: Female, Male Female | 30 Participants | 10 Participants | 40 Participants |
| Sex: Female, Male Male | 20 Participants | 45 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 55 |
| other Total, other adverse events | 4 / 50 | 2 / 55 |
| serious Total, serious adverse events | 3 / 50 | 5 / 55 |
Outcome results
Primary
Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death
The number of participants meeting criteria for a composite of hospital admissions, emergency department visits, urgent clinic visits for heart failure and death after admission with acute decompensated heart failure (ADHF) was determined.
Time frame: Up to 26 weeks
Population: This analysis includes participants who started the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dapagliflozin | Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death | 0 Participants |
| Placebo | Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death | 3 Participants |
Secondary
6-Minute Walk Distance (6MWD)
The 6-Minute Walk Distance (6MWD) test measures the distance, in meters, that a patient can quickly walk on a flat, hard surface in a period of 6 minutes
Time frame: Baseline, Week 12, Week 26
Population: This analysis includes participants who started the study drug and who were physically able to partake in this assessment at the indicated study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapagliflozin | 6-Minute Walk Distance (6MWD) | Baseline | 893.42 meters (m) | Standard Deviation 394.61 |
| Dapagliflozin | 6-Minute Walk Distance (6MWD) | Week 12 | 1185.76 meters (m) | Standard Deviation 321.27 |
| Dapagliflozin | 6-Minute Walk Distance (6MWD) | Week 26 | 995.23 meters (m) | Standard Deviation 414.59 |
| Placebo | 6-Minute Walk Distance (6MWD) | Baseline | 1109.05 meters (m) | Standard Deviation 1271.43 |
| Placebo | 6-Minute Walk Distance (6MWD) | Week 12 | 1548.23 meters (m) | Standard Deviation 1807.13 |
| Placebo | 6-Minute Walk Distance (6MWD) | Week 26 | 1123.19 meters (m) | Standard Deviation 379.64 |
Secondary
Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score
Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) assesses patients' perception of their heart failure and measures the impact of heart failure symptoms. The CHQ-SAS contains 16 standardized questions that assess dyspnea during daily activities, fatigue and emotional function. Items are rated on a 7-point Likert scale ranging from 1 to 7. The total score is the mean of the item scores and higher scores indicate better quality of life.
Time frame: Baseline, Week 12, Week 26
Population: This analysis includes participants who started the study drug and attended the indicated study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapagliflozin | Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score | Baseline | 4.04 score on a scale | Standard Deviation 1.51 |
| Dapagliflozin | Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score | Week 12 | 5.25 score on a scale | Standard Deviation 1.05 |
| Dapagliflozin | Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score | Week 26 | 5.27 score on a scale | Standard Deviation 0.93 |
| Placebo | Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score | Baseline | 4.07 score on a scale | Standard Deviation 1.31 |
| Placebo | Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score | Week 12 | 5.34 score on a scale | Standard Deviation 1.14 |
| Placebo | Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score | Week 26 | 5.27 score on a scale | Standard Deviation 1.17 |
Secondary
Hemoglobin A1C (HbA1c) Level
HbA1c was quantified by blood test, in participants with type 2 diabetes (T2D). Higher percentages of glycated hemoglobin on red blood cells (RBCs) indicate higher blood glucose levels in the previous three months. A normal HbA1c level is below 5.7 percent.
Time frame: Baseline, Week 12, Week 26
Population: This analysis includes participants with type 2 diabetes who started the study drug and attended the indicated study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapagliflozin | Hemoglobin A1C (HbA1c) Level | Week 26 | 9.47 percent of RBCs with glycated hemoglobin | Standard Deviation 2.84 |
| Dapagliflozin | Hemoglobin A1C (HbA1c) Level | Baseline | 9.41 percent of RBCs with glycated hemoglobin | Standard Deviation 2.33 |
| Dapagliflozin | Hemoglobin A1C (HbA1c) Level | Week 12 | 8.62 percent of RBCs with glycated hemoglobin | Standard Deviation 2.12 |
| Placebo | Hemoglobin A1C (HbA1c) Level | Baseline | 8.98 percent of RBCs with glycated hemoglobin | Standard Deviation 1.91 |
| Placebo | Hemoglobin A1C (HbA1c) Level | Week 12 | 8.47 percent of RBCs with glycated hemoglobin | Standard Deviation 2.88 |
| Placebo | Hemoglobin A1C (HbA1c) Level | Week 26 | 7.84 percent of RBCs with glycated hemoglobin | Standard Deviation 2.38 |
Secondary
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: Baseline, Week 12, Week 26
Population: This analysis includes participants who started the study drug and attended the indicated study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapagliflozin | Kansas City Cardiomyopathy Questionnaire (KCCQ) Score | Week 12 | 62.40 score on a scale | Standard Deviation 37.52 |
| Dapagliflozin | Kansas City Cardiomyopathy Questionnaire (KCCQ) Score | Baseline | 55.72 score on a scale | Standard Deviation 23.23 |
| Dapagliflozin | Kansas City Cardiomyopathy Questionnaire (KCCQ) Score | Week 26 | 83.36 score on a scale | Standard Deviation 13.51 |
| Placebo | Kansas City Cardiomyopathy Questionnaire (KCCQ) Score | Baseline | 50.71 score on a scale | Standard Deviation 25.1 |
| Placebo | Kansas City Cardiomyopathy Questionnaire (KCCQ) Score | Week 12 | 66.95 score on a scale | Standard Deviation 36.93 |
| Placebo | Kansas City Cardiomyopathy Questionnaire (KCCQ) Score | Week 26 | 80.38 score on a scale | Standard Deviation 17.46 |
Secondary
Left Atrial Diameter
The normal range for left atrial diameter is 2.0 to 4.0 centimeters (cm). The left atrium increases in size with heart conditions.
Time frame: Baseline, Week 12, Week 26
Population: This analysis includes participants who started the study drug and attended the indicated study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapagliflozin | Left Atrial Diameter | Baseline | 4.47 centimeters | Standard Deviation 0.79 |
| Dapagliflozin | Left Atrial Diameter | Week 12 | 4.55 centimeters | Standard Deviation 0.82 |
| Dapagliflozin | Left Atrial Diameter | Week 26 | 4.30 centimeters | Standard Deviation 1.12 |
| Placebo | Left Atrial Diameter | Baseline | 4.32 centimeters | Standard Deviation 0.75 |
| Placebo | Left Atrial Diameter | Week 12 | 4.91 centimeters | Standard Deviation 0.43 |
| Placebo | Left Atrial Diameter | Week 26 | 4.31 centimeters | Standard Deviation 0.72 |
Secondary
N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels
The heart failure, disease-specific biomarker N-terminal (NT)-pro hormone BNP (NT-proBNP) is a non-active prohormone. Levels increase when heart failure develops or gets worse and levels reduce when heart failure is stable.
Time frame: Baseline, Week 12, Week 26
Population: This analysis includes participants who started the study drug and attended the indicated study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapagliflozin | N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels | Baseline | 1947.38 picograms per milliliter (pg/mL) | Standard Deviation 2641.03 |
| Dapagliflozin | N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels | Week 12 | 589.25 picograms per milliliter (pg/mL) | Standard Deviation 391.37 |
| Dapagliflozin | N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels | Week 26 | 674.50 picograms per milliliter (pg/mL) | Standard Deviation 388.71 |
| Placebo | N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels | Baseline | 1469.86 picograms per milliliter (pg/mL) | Standard Deviation 1713.87 |
| Placebo | N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels | Week 12 | 1083.00 picograms per milliliter (pg/mL) | Standard Deviation 1554.99 |
| Placebo | N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels | Week 26 | 730.00 picograms per milliliter (pg/mL) | Standard Deviation 541.06 |
Secondary
Number of Participants Dying From Cardiovascular Reasons
The number of participants dying due to cardiovascular reasons was documented.
Time frame: Up to Week 26
Population: This analysis includes participants who started the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dapagliflozin | Number of Participants Dying From Cardiovascular Reasons | 0 Participants |
| Placebo | Number of Participants Dying From Cardiovascular Reasons | 0 Participants |
Secondary
Number of Participants With Acute Kidney Injury
The number of participants experiencing acute kidney injury was documented.
Time frame: Up to Week 26
Population: This analysis includes participants who started the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dapagliflozin | Number of Participants With Acute Kidney Injury | 0 Participants |
| Placebo | Number of Participants With Acute Kidney Injury | 0 Participants |
Secondary
Number of Participants With Non-fatal Myocardial Infarction (MI)
The number of participants with non-fatal myocardial infarction (MI) was documented.
Time frame: Up to Week 26
Population: This analysis includes participants who started the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dapagliflozin | Number of Participants With Non-fatal Myocardial Infarction (MI) | 0 Participants |
| Placebo | Number of Participants With Non-fatal Myocardial Infarction (MI) | 0 Participants |
Secondary
Number of Participants With Stroke
The number of participants experiencing a stroke was documented.
Time frame: Up to Week 26
Population: This analysis includes participants who started the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dapagliflozin | Number of Participants With Stroke | 1 Participants |
| Placebo | Number of Participants With Stroke | 0 Participants |
Secondary
Serum Magnesium
Normal levels of serum magnesium are between 1.7 and 2.3 milligrams per deciliter (mg/dL).
Time frame: Baseline, Week 12, Week 26
Population: This analysis includes participants who started the study drug and attended the indicated study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapagliflozin | Serum Magnesium | Week 26 | 2.13 mg/dL | Standard Deviation 0.17 |
| Dapagliflozin | Serum Magnesium | Baseline | 2.01 mg/dL | Standard Deviation 0.27 |
| Dapagliflozin | Serum Magnesium | Week 12 | 2.11 mg/dL | Standard Deviation 0.22 |
| Placebo | Serum Magnesium | Week 26 | 1.98 mg/dL | Standard Deviation 0.27 |
| Placebo | Serum Magnesium | Baseline | 1.92 mg/dL | Standard Deviation 0.48 |
| Placebo | Serum Magnesium | Week 12 | 2.02 mg/dL | Standard Deviation 0.23 |
Secondary
Systolic Blood Pressure
Systolic blood pressure is measured in millimeters of mercury (mmHg). A normal systolic blood pressure level is less than 120 mmHg.
Time frame: Baseline, Week 12, Week 26
Population: This analysis includes participants who started the study drug and attended the indicated study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapagliflozin | Systolic Blood Pressure | Baseline | 124.39 mmHg | Standard Deviation 14.51 |
| Dapagliflozin | Systolic Blood Pressure | Week 12 | 118.15 mmHg | Standard Deviation 21.57 |
| Dapagliflozin | Systolic Blood Pressure | Week 26 | 131.69 mmHg | Standard Deviation 21.76 |
| Placebo | Systolic Blood Pressure | Baseline | 125.36 mmHg | Standard Deviation 17.38 |
| Placebo | Systolic Blood Pressure | Week 12 | 124.31 mmHg | Standard Deviation 19.88 |
| Placebo | Systolic Blood Pressure | Week 26 | 136.79 mmHg | Standard Deviation 23.69 |
Secondary
Weight
Weight is measured in kilograms.
Time frame: Baseline,Week 12, Week 26
Population: This analysis includes participants who started the study drug and attended the indicated study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapagliflozin | Weight | Week 26 | 98.06 kilograms | Standard Deviation 29.05 |
| Dapagliflozin | Weight | Baseline | 101.21 kilograms | Standard Deviation 35.77 |
| Dapagliflozin | Weight | Week 12 | 95.93 kilograms | Standard Deviation 30.26 |
| Placebo | Weight | Baseline | 103.59 kilograms | Standard Deviation 27.77 |
| Placebo | Weight | Week 12 | 101.18 kilograms | Standard Deviation 20.53 |
| Placebo | Weight | Week 26 | 100.18 kilograms | Standard Deviation 18.55 |