Trial Outcomes & Findings for Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension (NCT NCT03006471)
NCT ID: NCT03006471
Last Updated: 2020-11-09
Results Overview
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
COMPLETED
PHASE4
30 participants
Week 12
2020-11-09
Participant Flow
Participant milestones
| Measure |
Dapagliflozin
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension
Baseline characteristics by cohort
| Measure |
Dapagliflozin
n=15 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=15 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 Years
STANDARD_DEVIATION 7 • n=5 Participants
|
50 Years
STANDARD_DEVIATION 5 • n=7 Participants
|
48.5 Years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
15 Mexico
n=5 Participants
|
15 Mexico
n=7 Participants
|
30 Mexico
n=5 Participants
|
|
Body weight
|
74 kg
STANDARD_DEVIATION 10 • n=5 Participants
|
80 kg
STANDARD_DEVIATION 12 • n=7 Participants
|
77 kg
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Body Mass Index
|
30 kg/m^2
STANDARD_DEVIATION 2 • n=5 Participants
|
31 kg/m^2
STANDARD_DEVIATION 2 • n=7 Participants
|
30.5 kg/m^2
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Office Systolic blood pressure
|
127 mmHg
STANDARD_DEVIATION 7 • n=5 Participants
|
127 mmHg
STANDARD_DEVIATION 5 • n=7 Participants
|
127 mmHg
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Office Diastolic blood pressure
|
80.0 mmHg
STANDARD_DEVIATION 6.0 • n=5 Participants
|
81.0 mmHg
STANDARD_DEVIATION 7.0 • n=7 Participants
|
80.5 mmHg
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Fasting plasma glucose
|
6.3 mmol/L
STANDARD_DEVIATION 0.3 • n=5 Participants
|
6.0 mmol/L
STANDARD_DEVIATION 0.4 • n=7 Participants
|
6.15 mmol/L
STANDARD_DEVIATION 0.35 • n=5 Participants
|
|
2-hours plasma glucose after a oral glucose tolerance test
|
8.4 mmol/L
STANDARD_DEVIATION 1.4 • n=5 Participants
|
7.9 mmol/L
STANDARD_DEVIATION 2.4 • n=7 Participants
|
8.15 mmol/L
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Glycated hemoglobin A1c (A1C)
|
5.9 percentage of A1C
STANDARD_DEVIATION 0.5 • n=5 Participants
|
5.8 percentage of A1C
STANDARD_DEVIATION 0.3 • n=7 Participants
|
5.85 percentage of A1C
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
24-hours Systolic Blood pressure
|
121 mmHg
STANDARD_DEVIATION 8 • n=5 Participants
|
119 mmHg
STANDARD_DEVIATION 9 • n=7 Participants
|
120 mmHg
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
24-hours Diastolic Blood Pressure
|
73 mmHg
STANDARD_DEVIATION 7 • n=5 Participants
|
74 mmHg
STANDARD_DEVIATION 7 • n=7 Participants
|
73.5 mmHg
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Daytime Systolic Blood Pressure
|
124 mmHg
STANDARD_DEVIATION 8 • n=5 Participants
|
122 mmHg
STANDARD_DEVIATION 11 • n=7 Participants
|
123 mmHg
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Daytime Diastolic Blood Pressure
|
75 mmHg
STANDARD_DEVIATION 7 • n=5 Participants
|
76 mmHg
STANDARD_DEVIATION 7 • n=7 Participants
|
75.5 mmHg
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Nightime Systolic Blood Pressure
|
114 mmHg
STANDARD_DEVIATION 11 • n=5 Participants
|
114 mmHg
STANDARD_DEVIATION 13 • n=7 Participants
|
114 mmHg
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Nightime Diastolic Blood Pressure
|
68 mmHg
STANDARD_DEVIATION 7 • n=5 Participants
|
69 mmHg
STANDARD_DEVIATION 8 • n=7 Participants
|
68.5 mmHg
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Systolic Blood Pressure weighted Standard Deviation
|
9.2 mmHg
STANDARD_DEVIATION 1.9 • n=5 Participants
|
9.8 mmHg
STANDARD_DEVIATION 3.3 • n=7 Participants
|
9.5 mmHg
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Diastolic Blood Pressure weighted Standard Deviation
|
6.9 mmHg
STANDARD_DEVIATION 1.8 • n=5 Participants
|
7.7 mmHg
STANDARD_DEVIATION 2.0 • n=7 Participants
|
7.3 mmHg
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Coefficient of variation of 24-hours, Systolic Blood Pressure
|
8.9 Percentage of Coefficient of variability
STANDARD_DEVIATION 2.2 • n=5 Participants
|
9.2 Percentage of Coefficient of variability
STANDARD_DEVIATION 3.0 • n=7 Participants
|
9.05 Percentage of Coefficient of variability
STANDARD_DEVIATION 1.91 • n=5 Participants
|
|
Coefficient of variation of 24-hours, Diastolic Blood Pressure
|
11.1 Percentage of Coefficient of variability
STANDARD_DEVIATION 2.9 • n=5 Participants
|
12.3 Percentage of Coefficient of variability
STANDARD_DEVIATION 2.9 • n=7 Participants
|
11.7 Percentage of Coefficient of variability
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Coefficient of variation of daytime, Systolic Blood Pressure
|
7.3 Percentage of Coefficient of variability
STANDARD_DEVIATION 2.2 • n=5 Participants
|
8.1 Percentage of Coefficient of variability
STANDARD_DEVIATION 3.4 • n=7 Participants
|
7.7 Percentage of Coefficient of variability
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Coefficient of variation of daytime, Diastolic Blood Pressure
|
8.9 Percentage of Coefficient of variability
STANDARD_DEVIATION 2.0 • n=5 Participants
|
10.0 Percentage of Coefficient of variability
STANDARD_DEVIATION 3.6 • n=7 Participants
|
9.45 Percentage of Coefficient of variability
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Coefficient of variation of nighttime, Systolic Blood Pressure
|
8.3 Percentage of Coefficient of variability
STANDARD_DEVIATION 2.1 • n=5 Participants
|
8.9 Percentage of Coefficient of variability
STANDARD_DEVIATION 3.3 • n=7 Participants
|
8.6 Percentage of Coefficient of variability
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Coefficient of variation of nighttime, Diastolic Blood Pressure
|
10.9 Percentage of Coefficient of variability
STANDARD_DEVIATION 4.2 • n=5 Participants
|
11.9 Percentage of Coefficient of variability
STANDARD_DEVIATION 3.8 • n=7 Participants
|
11.4 Percentage of Coefficient of variability
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Average real variability of Systolic Blood Pressure
|
9.5 mmHg
STANDARD_DEVIATION 2.5 • n=5 Participants
|
9.3 mmHg
STANDARD_DEVIATION 2.0 • n=7 Participants
|
9.4 mmHg
STANDARD_DEVIATION 2.25 • n=5 Participants
|
|
Average real variability of Diastolic Blood Pressure
|
6.5 mmHg
STANDARD_DEVIATION 1.4 • n=5 Participants
|
6.6 mmHg
STANDARD_DEVIATION 1.2 • n=7 Participants
|
6.55 mmHg
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Number of Participants with a Nondipper circadian blood pressure pattern
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Number of Participants with a Dipper circadian blood pressure pattern
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Number of Participants with a Dipper reverse circadian blood pressure pattern
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Daytime Mean Arterial Pressure
|
92 mmHg
STANDARD_DEVIATION 7 • n=5 Participants
|
91 mmHg
STANDARD_DEVIATION 8 • n=7 Participants
|
91.5 mmHg
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Nighttime Mean Arterial Pressure
|
85 mmHg
STANDARD_DEVIATION 8 • n=5 Participants
|
84 mmHg
STANDARD_DEVIATION 9 • n=7 Participants
|
84.5 mmHg
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Daytime hypertensive load
|
30.7 mmHg
STANDARD_DEVIATION 23.5 • n=5 Participants
|
29.7 mmHg
STANDARD_DEVIATION 29.5 • n=7 Participants
|
30.2 mmHg
STANDARD_DEVIATION 26.5 • n=5 Participants
|
|
Nocturnal hypertensive load
|
51.1 mmHg
STANDARD_DEVIATION 32.3 • n=5 Participants
|
45.2 mmHg
STANDARD_DEVIATION 32.4 • n=7 Participants
|
48.15 mmHg
STANDARD_DEVIATION 32.35 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: 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
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
24-hours Systolic Blood Pressure at Week 12
|
117 mmHg
Standard Deviation 11
|
120 mmHg
Standard Deviation 13
|
PRIMARY outcome
Timeframe: Week 12Population: 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
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
24-hours Diastolic Blood Pressure at Week 12
|
73 mmHg
Standard Deviation 8
|
75 mmHg
Standard Deviation 9
|
PRIMARY outcome
Timeframe: Week 12Population: 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
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 am. to 11 p.m. by oscillometric method Microlife WatchBP O3
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Daytime Systolic Blood Pressure at Week 12
|
121 mmHg
Standard Deviation 11
|
122 mmHg
Standard Deviation 14
|
PRIMARY outcome
Timeframe: Week 12Population: 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
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to p.m. by oscillometric method Microlife WatchBP O3
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Daytime Diastolic Blood Pressure at Week 12
|
76 mmHg
Standard Deviation 9
|
77 mmHg
Standard Deviation 10
|
PRIMARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Nighttime Systolic Blood Pressure at Week 12
|
108 mmHg
Standard Deviation 10
|
115 mmHg
Standard Deviation 11
|
PRIMARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Nighttime Diastolic Blood Pressure at Week 12
|
67 mmHg
Standard Deviation 7
|
72 mmHg
Standard Deviation 8
|
PRIMARY outcome
Timeframe: Week 12Population: 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
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Systolic Blood Pressure Weighted Standard Deviation at Week 12
|
9.8 mmHg
Standard Deviation 3.5
|
10.3 mmHg
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: Week 12Population: 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
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Diastolic Blood Pressure Weighted Standard Deviation at Week 12
|
8.0 mmHg
Standard Deviation 3.6
|
8.3 mmHg
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: Week 12Population: 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
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12
|
9.9 Percentage of Coefficient of variability
Standard Deviation 3.4
|
9.5 Percentage of Coefficient of variability
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: Week 12Population: 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
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12
|
12.3 Percentage of Coefficient of variability
Standard Deviation 4.8
|
11.3 Percentage of Coefficient of variability
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12
|
7.7 Percentage of Coefficient of variability
Standard Deviation 2.4
|
8.4 Percentage of Coefficient of variability
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12
|
10.2 Percentage of Coefficient of variability
Standard Deviation 4.2
|
9.2 Percentage of Coefficient of variability
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12
|
8.4 Percentage of Coefficient of variability
Standard Deviation 3.2
|
10.6 Percentage of Coefficient of variability
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12
|
12.3 Percentage of Coefficient of variability
Standard Deviation 4.7
|
13.5 Percentage of Coefficient of variability
Standard Deviation 5.0
|
PRIMARY outcome
Timeframe: Week 12Population: 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
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Average Real Variability of Systolic Blood Pressure at Week 12
|
10.0 mmHg
Standard Deviation 2.6
|
9.2 mmHg
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: Week 12Population: 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
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Average Real Variability of Diastolic Blood Pressure at Week 12
|
6.8 mmHg
Standard Deviation 1.4
|
7.0 mmHg
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: Week 12Population: 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
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12
|
4 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: 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
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12
|
8 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: 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
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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
The body weight was measured with a bioimpedance balance
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Body Weight at Week 12
|
73 kg
Standard Deviation 10
|
78 kg
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Week 12Population: 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
Body Mas Index was calculated with the Quetelet index formula
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Body Mass Index at Week 12
|
28 kg/m^2
Standard Deviation 2
|
29 kg/m^2
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Week 12Population: 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
Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Office Systolic Blood Pressure at Week 12
|
119 mmHg
Standard Deviation 8
|
130 mmHg
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Week 12Population: 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
Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Office of Diastolic Blood Pressure at Week 12
|
75 mmHg
Standard Deviation 6
|
82 mmHg
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Week 12Population: 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
The fasting glucose levels was evaluated with enzymatic/colorimetric techniques
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Fasting Plasma Glucose Levels at Week 12
|
5.8 mmol/L
Standard Deviation 0.5
|
6.1 mmol/L
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Week 12Population: 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
2-hours plasma glucose after a oral glucose tolerance test (75 g of glucose load). Glucose was evaluated with enzymatic/ colorimetric technique
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12
|
7.8 mmol/L
Standard Deviation 1.8
|
8.3 mmol/L
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Week 12Population: 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
A1C was evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA)
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Glycated Hemoglobin A1c (A1C) at Week 12
|
5.4 percentage of A1C
Standard Deviation 0.4
|
5.9 percentage of A1C
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Daytime Mean Arterial Pressure at Week 12
|
92 mmHg
Standard Deviation 11
|
92 mmHg
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Nighttime Mean Arterial Pressure at Week 12
|
84 mmHg
Standard Deviation 9
|
87 mmHg
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Daytime Hypertensive Load at Week 12
|
28.6 percentage of hypertensive load
Standard Deviation 29.8
|
34.1 percentage of hypertensive load
Standard Deviation 35.7
|
SECONDARY outcome
Timeframe: Week 12Population: 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
The Hypertensive Load was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to a.m. by oscillometric method Microlife WatchBP O3
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Nocturnal Hypertensive Load at Week 12
|
38.1 percentage of hypertensive load
Standard Deviation 32.0
|
52.0 percentage of hypertensive load
Standard Deviation 32.0
|
SECONDARY outcome
Timeframe: Week 12Population: 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
Prediabetes was diagnosed with the criteria of the American Diabetes Association.
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Number of Participants With Prediabetes at Week 12
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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
Prehypertension was diagnosed with the criteria of the Eighth Joint National Committee.
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Number of Participants With Prehypertension at Week 12
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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
Criteria of the American Diabetes Association and Eighth Joint National Committee were used to diagnosed prediabetes and prehypertension.
Outcome measures
| Measure |
Dapagliflozin
n=13 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=13 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Number of Participants With Prediabetes Plus Prehypertension at Week 12
|
4 Participants
|
0 Participants
|
Adverse Events
Dapagliflozin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dapagliflozin
n=15 participants at risk
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=15 participants at risk
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Infections and infestations
Cervicovaginal infection
|
20.0%
3/15 • Number of events 3 • Through study completion, an average of 12 weeks
|
0.00%
0/15 • Through study completion, an average of 12 weeks
|
|
Renal and urinary disorders
Urinary tract infections
|
13.3%
2/15 • Number of events 2 • Through study completion, an average of 12 weeks
|
0.00%
0/15 • Through study completion, an average of 12 weeks
|
Additional Information
DR. MANUEL GONZALEZ ORTIZ
INSITITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place