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Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension

Sponsor
University of Guadalajara (Other)
Overall Status
Completed
CT.gov ID
NCT03006471
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
27
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prediabetes is defined as an intermediate metabolic state that leads to the development of type 2 diabetes mellitus (DM2) and the prehypertension is a category assigned to identify patients who are at risk of developing hypertension (AH), in both pathologies the abnormalities in the variation of blood pressure (BP) has been related to organ damage, its evaluation is performed by ambulatory blood pressure monitoring (ABPM).

Dapagliflozin is a selective and reversible inhibitor of the sodium-glucose co-transporter type 2 (SGLT-2), which reduces renal reabsorption of glucose and promotes the excretion of glucose through the urine, in the way that glucose blood. Another reported effects is the decrease on BP, so it would be interesting to evaluate this effects in patients with prediabetes and prehypertension, as a potential therapy to treat disorders and to prevent progression to DM2 and Hypertension, respectively.

The aim of this study is to evaluate the effect of Dapagliflozin on variability of blood pressure in patients with prediabetes and prehypertension without pharmacological treatment.

The investigators hypothesis is that the administration of dapagliflozin decreases variability of blood pressure in patients with prediabetes and prehypertension without pharmacological treatment.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

A randomized, double-blind, placebo-controlled clinical trial in 30 patients with a diagnosis of prediabetes and prehypertension without treatment.

They will be assigned randomly two groups of 15 patients each to receive 10 mg of Dapagliflozin (Forxiga, Astra Zeneca) or placebo, one per day before breakfast during 12 weeks.

There will be calculated body mass index (BMI) and blood pressure variability. This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.

Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2/ exact fisher test, will be used for differences inter-group Mann-Whitney U Test and coefficient of variation, Wilcoxon Test and index of variability for the within-groups differences. It will be considered statistical significance p ≤0.05.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Dapagliflozin on Blood Pressure Variability in Patients With Prediabetes and Prehypertension Without Pharmacological Treatment
Actual Study Start Date :
Mar 30, 2016
Actual Primary Completion Date :
Mar 30, 2018
Actual Study Completion Date :
Jun 29, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dapagliflozin

Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.

Drug: Dapagliflozin
10 mg, one per day before breakfast during 12 weeks.
Other Names:
  • Forxiga

    		•
    Placebo Comparator: Placebo

    Placebo capsules, one per day before breakfast during 12 weeks.

    Drug: Placebo - Cap
    one per day before breakfast during 12 weeks.
    Other Names:
  • Calcined magnesium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 24-hours Systolic Blood Pressure at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

    2. 24-hours Diastolic Blood Pressure at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

    3. Daytime Systolic Blood Pressure at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 am. to 11 p.m. by oscillometric method Microlife WatchBP O3

    4. Daytime Diastolic Blood Pressure at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to p.m. by oscillometric method Microlife WatchBP O3

    5. Nighttime Systolic Blood Pressure at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3

    6. Nighttime Diastolic Blood Pressure at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3

    7. Systolic Blood Pressure Weighted Standard Deviation at Week 12 [Week 12]

      Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

    8. Diastolic Blood Pressure Weighted Standard Deviation at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

    9. Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

    10. Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

    11. Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m to 11 p.m. by oscillometric method Microlife WatchBP O3

    12. Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3

    13. Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3

    14. Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3

    15. Average Real Variability of Systolic Blood Pressure at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

    16. Average Real Variability of Diastolic Blood Pressure at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

    17. Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

    18. Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

    19. Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12 [Week 12]

      Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

    Secondary Outcome Measures

    1. Body Weight at Week 12 [Week 12]

      The body weight was measured with a bioimpedance balance

    2. Body Mass Index at Week 12 [Week 12]

      Body Mas Index was calculated with the Quetelet index formula

    3. Office Systolic Blood Pressure at Week 12 [Week 12]

      Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)

    4. Office of Diastolic Blood Pressure at Week 12 [Week 12]

      Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)

    5. Fasting Plasma Glucose Levels at Week 12 [Week 12]

      The fasting glucose levels was evaluated with enzymatic/colorimetric techniques

    6. 2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12 [Week 12]

      2-hours plasma glucose after a oral glucose tolerance test (75 g of glucose load). Glucose was evaluated with enzymatic/ colorimetric technique

    7. Glycated Hemoglobin A1c (A1C) at Week 12 [Week 12]

      A1C was evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA)

    8. Daytime Mean Arterial Pressure at Week 12 [Week 12]

      The mean arterial pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3

    9. Nighttime Mean Arterial Pressure at Week 12 [Week 12]

      The Mean Arterial Pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3

    10. Daytime Hypertensive Load at Week 12 [Week 12]

      The hypertensive load was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3

    11. Nocturnal Hypertensive Load at Week 12 [Week 12]

      The Hypertensive Load was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to a.m. by oscillometric method Microlife WatchBP O3

    12. Number of Participants With Prediabetes at Week 12 [Week 12]

      Prediabetes was diagnosed with the criteria of the American Diabetes Association.

    13. Number of Participants With Prehypertension at Week 12 [Week 12]

      Prehypertension was diagnosed with the criteria of the Eighth Joint National Committee.

    14. Number of Participants With Prediabetes Plus Prehypertension at Week 12 [Week 12]

      Criteria of the American Diabetes Association and Eighth Joint National Committee were used to diagnosed prediabetes and prehypertension.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Informed consent signed

    • Patients both sexes, age between 30 and 60 years

    • Diagnosis of prediabetes according American Diabetes Association criteria (fasting blood glucose levels between 100-126 mg/dl; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl; or glycosylated hemoglobin between 5.7-6.4%)

    • Diagnosis of prehypertension according (JNC8) Eighth Joint National Committee blood pressure between 120-139/ 80-89 mmHg.

    Exclusion Criteria:

    • Women with confirmed or suspected pregnancy

    • Women under lactation and/or puerperium

    • Hypersensibility to ingredients of intervention

    • Physical impossibility for taking pills

    • Known uncontrolled renal, hepatic, heart or thyroid diseased

    • Diabetes diagnosis

    • Previous treatment for glucose or blood pressure Triglycerides ≥400 mg/dL

    • Total cholesterol ≥240 mg/dL

    • History of cardiovascular disease

    • Worker per shift / night

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara Guadalajara Jalisco Mexico 44340

    Sponsors and Collaborators

    • University of Guadalajara

    Investigators

    • Principal Investigator: MANUEL GONZALEZ, PhD, University of Guadalajara

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Manuel González Ortiz, PhD, University of Guadalajara
    ClinicalTrials.gov Identifier:
    NCT03006471
    Other Study ID Numbers:
    • DAPA-BP variability
    First Posted:
    Dec 30, 2016
    Last Update Posted:
    Nov 9, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Manuel González Ortiz, PhD, University of Guadalajara
    Prediabetes
    Prehypertension
    Variability of blood pressure
    ABPM
    Dapagliflozin
    SGLT2
    Additional relevant MeSH terms:
    Prehypertension
    Prediabetic State
    Glucose Intolerance
    Dapagliflozin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Period Title: Overall Study
    STARTED 15 15
    COMPLETED 13 13
    NOT COMPLETED 2 2

    Baseline Characteristics

    Arm/Group Title Dapagliflozin Placebo Total
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks. Total of all reporting groups
    Overall Participants 15 15 30
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    47
    (7)
    50
    (5)
    48.5
    (6)
    Sex: Female, Male (Count of Participants)
    Female
    11
    73.3%
    8
    53.3%
    19
    63.3%
    Male
    4
    26.7%
    7
    46.7%
    11
    36.7%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    15
    100%
    15
    100%
    30
    100%
    Not Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Mexico) [Number]
    Mexico
    15
    15
    30
    Body weight (kg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg]
    74
    (10)
    80
    (12)
    77
    (11)
    Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    30
    (2)
    31
    (2)
    30.5
    (2)
    Office Systolic blood pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    127
    (7)
    127
    (5)
    127
    (6)
    Office Diastolic blood pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    80.0
    (6.0)
    81.0
    (7.0)
    80.5
    (6.5)
    Fasting plasma glucose (mmol/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmol/L]
    6.3
    (0.3)
    6.0
    (0.4)
    6.15
    (0.35)
    2-hours plasma glucose after a oral glucose tolerance test (mmol/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmol/L]
    8.4
    (1.4)
    7.9
    (2.4)
    8.15
    (1.9)
    Glycated hemoglobin A1c (A1C) (percentage of A1C) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [percentage of A1C]
    5.9
    (0.5)
    5.8
    (0.3)
    5.85
    (0.4)
    24-hours Systolic Blood pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    121
    (8)
    119
    (9)
    120
    (8.5)
    24-hours Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    73
    (7)
    74
    (7)
    73.5
    (7)
    Daytime Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    124
    (8)
    122
    (11)
    123
    (9.5)
    Daytime Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    75
    (7)
    76
    (7)
    75.5
    (7)
    Nightime Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    114
    (11)
    114
    (13)
    114
    (12)
    Nightime Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    68
    (7)
    69
    (8)
    68.5
    (7.5)
    Systolic Blood Pressure weighted Standard Deviation (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    9.2
    (1.9)
    9.8
    (3.3)
    9.5
    (2.6)
    Diastolic Blood Pressure weighted Standard Deviation (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    6.9
    (1.8)
    7.7
    (2.0)
    7.3
    (1.9)
    Coefficient of variation of 24-hours, Systolic Blood Pressure (Percentage of Coefficient of variability) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Percentage of Coefficient of variability]
    8.9
    (2.2)
    9.2
    (3.0)
    9.05
    (1.91)
    Coefficient of variation of 24-hours, Diastolic Blood Pressure (Percentage of Coefficient of variability) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Percentage of Coefficient of variability]
    11.1
    (2.9)
    12.3
    (2.9)
    11.7
    (2.9)
    Coefficient of variation of daytime, Systolic Blood Pressure (Percentage of Coefficient of variability) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Percentage of Coefficient of variability]
    7.3
    (2.2)
    8.1
    (3.4)
    7.7
    (2.8)
    Coefficient of variation of daytime, Diastolic Blood Pressure (Percentage of Coefficient of variability) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Percentage of Coefficient of variability]
    8.9
    (2.0)
    10.0
    (3.6)
    9.45
    (2.8)
    Coefficient of variation of nighttime, Systolic Blood Pressure (Percentage of Coefficient of variability) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Percentage of Coefficient of variability]
    8.3
    (2.1)
    8.9
    (3.3)
    8.6
    (2.7)
    Coefficient of variation of nighttime, Diastolic Blood Pressure (Percentage of Coefficient of variability) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Percentage of Coefficient of variability]
    10.9
    (4.2)
    11.9
    (3.8)
    11.4
    (4)
    Average real variability of Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    9.5
    (2.5)
    9.3
    (2.0)
    9.4
    (2.25)
    Average real variability of Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    6.5
    (1.4)
    6.6
    (1.2)
    6.55
    (1.3)
    Number of Participants with a Nondipper circadian blood pressure pattern (Count of Participants)
    Count of Participants [Participants]
    9
    60%
    8
    53.3%
    17
    56.7%
    Number of Participants with a Dipper circadian blood pressure pattern (Count of Participants)
    Count of Participants [Participants]
    5
    33.3%
    4
    26.7%
    9
    30%
    Number of Participants with a Dipper reverse circadian blood pressure pattern (Count of Participants)
    Count of Participants [Participants]
    1
    6.7%
    3
    20%
    4
    13.3%
    Daytime Mean Arterial Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    92
    (7)
    91
    (8)
    91.5
    (7.5)
    Nighttime Mean Arterial Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    85
    (8)
    84
    (9)
    84.5
    (8.9)
    Daytime hypertensive load (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    30.7
    (23.5)
    29.7
    (29.5)
    30.2
    (26.5)
    Nocturnal hypertensive load (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    51.1
    (32.3)
    45.2
    (32.4)
    48.15
    (32.35)

    Outcome Measures

    1. Primary Outcome
    Title 24-hours Systolic Blood Pressure at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmHg]
    117
    (11)
    120
    (13)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.755
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.046
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    2. Primary Outcome
    Title 24-hours Diastolic Blood Pressure at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmHg]
    73
    (8)
    75
    (9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.752
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.582
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    3. Primary Outcome
    Title Daytime Systolic Blood Pressure at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 am. to 11 p.m. by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmHg]
    121
    (11)
    122
    (14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.814
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.220
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    4. Primary Outcome
    Title Daytime Diastolic Blood Pressure at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to p.m. by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmHg]
    76
    (9)
    77
    (10)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.624
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    5. Primary Outcome
    Title Nighttime Systolic Blood Pressure at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmHg]
    108
    (10)
    115
    (11)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.906
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.017
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    6. Primary Outcome
    Title Nighttime Diastolic Blood Pressure at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmHg]
    67
    (7)
    72
    (8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.454
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.115
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    7. Primary Outcome
    Title Systolic Blood Pressure Weighted Standard Deviation at Week 12
    Description Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmHg]
    9.8
    (3.5)
    10.3
    (2.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.422
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.917
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    8. Primary Outcome
    Title Diastolic Blood Pressure Weighted Standard Deviation at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmHg]
    8.0
    (3.6)
    8.3
    (2.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.650
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.108
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    9. Primary Outcome
    Title Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [Percentage of Coefficient of variability]
    9.9
    (3.4)
    9.5
    (1.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.875
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values of waist circumference in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.196
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    10. Primary Outcome
    Title Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [Percentage of Coefficient of variability]
    12.3
    (4.8)
    11.3
    (2.2)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.552
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.087
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    11. Primary Outcome
    Title Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m to 11 p.m. by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [Percentage of Coefficient of variability]
    7.7
    (2.4)
    8.4
    (2.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.814
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.463
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    12. Primary Outcome
    Title Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [Percentage of Coefficient of variability]
    10.2
    (4.2)
    9.2
    (3.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.530
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.507
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    13. Primary Outcome
    Title Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [Percentage of Coefficient of variability]
    8.4
    (3.2)
    10.6
    (4.1)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.152
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.972
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    14. Primary Outcome
    Title Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [Percentage of Coefficient of variability]
    12.3
    (4.7)
    13.5
    (5.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.152
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.158
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    15. Primary Outcome
    Title Average Real Variability of Systolic Blood Pressure at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmHg]
    10.0
    (2.6)
    9.2
    (2.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.944
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.650
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    16. Primary Outcome
    Title Average Real Variability of Diastolic Blood Pressure at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmHg]
    6.8
    (1.4)
    7.0
    (1.1)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.087
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.345
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    17. Primary Outcome
    Title Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Count of Participants [Participants]
    4
    26.7%
    8
    53.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
    Comments Results showed in this section are the result of the differences between change of intervention group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.115
    Comments The threshold for statistical significance was p=0.05
    Method Chi-squared
    Comments
    18. Primary Outcome
    Title Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Count of Participants [Participants]
    8
    53.3%
    3
    20%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
    Comments Results showed in this section are the result of the differences between change of intervention groups
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.047
    Comments The threshold for statistical significance was p=0.05
    Method Chi-squared
    Comments
    19. Primary Outcome
    Title Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12
    Description Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Count of Participants [Participants]
    1
    6.7%
    2
    13.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
    Comments Results showed in this section are the result of the differences between change of intervention groups
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.539
    Comments The threshold for statistical significance was p=0.05
    Method Chi-squared
    Comments
    20. Secondary Outcome
    Title Body Weight at Week 12
    Description The body weight was measured with a bioimpedance balance
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [kg]
    73
    (10)
    78
    (12)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.844
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.010
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    21. Secondary Outcome
    Title Body Mass Index at Week 12
    Description Body Mas Index was calculated with the Quetelet index formula
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [kg/m^2]
    28
    (2)
    29
    (9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.814
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.011
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    22. Secondary Outcome
    Title Office Systolic Blood Pressure at Week 12
    Description Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmHg]
    119
    (8)
    130
    (7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.221
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    23. Secondary Outcome
    Title Office of Diastolic Blood Pressure at Week 12
    Description Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmHg]
    75
    (6)
    82
    (8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.461
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.011
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    24. Secondary Outcome
    Title Fasting Plasma Glucose Levels at Week 12
    Description The fasting glucose levels was evaluated with enzymatic/colorimetric techniques
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmol/L]
    5.8
    (0.5)
    6.1
    (0.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.285
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    25. Secondary Outcome
    Title 2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12
    Description 2-hours plasma glucose after a oral glucose tolerance test (75 g of glucose load). Glucose was evaluated with enzymatic/ colorimetric technique
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmol/L]
    7.8
    (1.8)
    8.3
    (2.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.701
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.081
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    26. Secondary Outcome
    Title Glycated Hemoglobin A1c (A1C) at Week 12
    Description A1C was evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA)
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [percentage of A1C]
    5.4
    (0.4)
    5.9
    (0.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.581
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values of HDL-cholesterol on dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    27. Secondary Outcome
    Title Daytime Mean Arterial Pressure at Week 12
    Description The mean arterial pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmHg]
    92
    (11)
    92
    (10)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.727
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.451
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    28. Secondary Outcome
    Title Nighttime Mean Arterial Pressure at Week 12
    Description The Mean Arterial Pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [mmHg]
    84
    (9)
    87
    (9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.463
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.043
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    29. Secondary Outcome
    Title Daytime Hypertensive Load at Week 12
    Description The hypertensive load was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [percentage of hypertensive load]
    28.6
    (29.8)
    34.1
    (35.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.807
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.754
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    30. Secondary Outcome
    Title Nocturnal Hypertensive Load at Week 12
    Description The Hypertensive Load was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to a.m. by oscillometric method Microlife WatchBP O3
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Mean (Standard Deviation) [percentage of hypertensive load]
    38.1
    (32.0)
    52.0
    (32.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values in placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.507
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin
    Comments Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.015
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    31. Secondary Outcome
    Title Number of Participants With Prediabetes at Week 12
    Description Prediabetes was diagnosed with the criteria of the American Diabetes Association.
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Count of Participants [Participants]
    7
    46.7%
    2
    13.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
    Comments Results showed in this section are the result of the differences between intervention groups
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.039
    Comments The threshold for statistical significance was p=0.05
    Method Fisher Exact
    Comments
    32. Secondary Outcome
    Title Number of Participants With Prehypertension at Week 12
    Description Prehypertension was diagnosed with the criteria of the Eighth Joint National Committee.
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Count of Participants [Participants]
    7
    46.7%
    1
    6.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
    Comments Results showed in this section are the result of the differences between intervention groups
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.011
    Comments
    Method Fisher Exact
    Comments
    33. Secondary Outcome
    Title Number of Participants With Prediabetes Plus Prehypertension at Week 12
    Description Criteria of the American Diabetes Association and Eighth Joint National Committee were used to diagnosed prediabetes and prehypertension.
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    Measure Participants 13 13
    Count of Participants [Participants]
    4
    26.7%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
    Comments Results showed in this section are the result of the differences between intervention groups
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.096
    Comments The threshold for statistical significance was p=0.05
    Method Fisher Exact
    Comments

    Adverse Events

    Time Frame Through study completion, an average of 12 weeks
    Adverse Event Reporting Description
    Arm/Group Title Dapagliflozin Placebo
    Arm/Group Description Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. Placebo capsules, one per day before breakfast during 12 weeks. Placebo - Cap: one per day before breakfast during 12 weeks.
    All Cause Mortality
    Dapagliflozin Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/15 (0%) 0/15 (0%)
    Serious Adverse Events
    Dapagliflozin Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/15 (0%) 0/15 (0%)
    Other (Not Including Serious) Adverse Events
    Dapagliflozin Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/15 (20%) 0/15 (0%)
    Infections and infestations
    Cervicovaginal infection 3/15 (20%) 3 0/15 (0%) 0
    Renal and urinary disorders
    Urinary tract infections 2/15 (13.3%) 2 0/15 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title DR. MANUEL GONZALEZ ORTIZ
    Organization INSITITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA
    Phone +52 3310585200 ext 34212
    Email uiec@prodigy.net.mx
    Responsible Party:
    Manuel González Ortiz, PhD, University of Guadalajara
    ClinicalTrials.gov Identifier:
    NCT03006471
    Other Study ID Numbers:
    • DAPA-BP variability
    First Posted:
    Dec 30, 2016
    Last Update Posted:
    Nov 9, 2020
    Last Verified:
    Oct 1, 2020