Trial Outcomes & Findings for Inhibition of Urinary Angiotensinogen and the Reduction of Blood Pressure by SGLT2 Inhibition in Patients With Type 2 Diabetes (NCT NCT02796170)
NCT ID: NCT02796170
Last Updated: 2022-11-01
Results Overview
Blood pressure was measured at baseline with a 24 hour ambulatory blood pressure machine (ABPM), and again after 6 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
Baseline to 6 weeks
Results posted on
2022-11-01
Participant Flow
Participant milestones
| Measure |
Dapagliflozin First Then Placebo
Participants underwent 6 weeks of Dapagliflozin (washout period for 2 weeks) and then crossed over to 6 weeks of placebo.
Dapagliflozin: 5mg pill taken once daily
Placebo: 5mg pill taken once daily.
|
Placebo First Then Dapagliflozin
Participants underwent 6 weeks of placebo (washout period for 2 weeks) and then crossed over to 6 weeks of Dapagliflozin.
Placebo: 5mg pill taken once daily Dapagliflozin: 5mg pill taken once daily
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Dapagliflozin First Then Placebo
Participants underwent 6 weeks of Dapagliflozin (washout period for 2 weeks) and then crossed over to 6 weeks of placebo.
Dapagliflozin: 5mg pill taken once daily
Placebo: 5mg pill taken once daily.
|
Placebo First Then Dapagliflozin
Participants underwent 6 weeks of placebo (washout period for 2 weeks) and then crossed over to 6 weeks of Dapagliflozin.
Placebo: 5mg pill taken once daily Dapagliflozin: 5mg pill taken once daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
Inhibition of Urinary Angiotensinogen and the Reduction of Blood Pressure by SGLT2 Inhibition in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Dapagliflozin First Then Placebo
n=8 Participants
Participants underwent 6 weeks of Dapagliflozin (washout period for 2 weeks) and then crossed over to 6 weeks of placebo.
Dapagliflozin: 5mg pill taken once daily
Placebo: 5mg pill taken once daily.
|
Placebo First Then Dapagliflozin
n=3 Participants
Participants underwent 6 weeks of placebo (washout period for 2 weeks) and then crossed over to 6 weeks of Dapagliflozin.
Placebo: 5mg pill taken once daily
Dapagliflozin: 5mg pill taken once daily
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
56.5 Years
STANDARD_DEVIATION 7.8 • n=99 Participants
|
52.7 Years
STANDARD_DEVIATION 6.7 • n=107 Participants
|
55.5 Years
STANDARD_DEVIATION 7.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
3 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Weight
|
89.3 Kg
STANDARD_DEVIATION 17.6 • n=99 Participants
|
114.5 Kg
STANDARD_DEVIATION 14.9 • n=107 Participants
|
96.2 Kg
STANDARD_DEVIATION 20.0 • n=206 Participants
|
|
BMI
|
32.6 Kg/m^2
STANDARD_DEVIATION 7.4 • n=99 Participants
|
38.2 Kg/m^2
STANDARD_DEVIATION 8.4 • n=107 Participants
|
34.1 Kg/m^2
STANDARD_DEVIATION 7.7 • n=206 Participants
|
|
HbA1c
|
8.0 HbA1c %
STANDARD_DEVIATION 1.3 • n=99 Participants
|
7.9 HbA1c %
STANDARD_DEVIATION 0.8 • n=107 Participants
|
8.0 HbA1c %
STANDARD_DEVIATION 1.1 • n=206 Participants
|
|
Average Systolic Blood pressure
|
119.0 mmHg
STANDARD_DEVIATION 8.5 • n=99 Participants
|
121.3 mmHg
STANDARD_DEVIATION 19.1 • n=107 Participants
|
119.6 mmHg
STANDARD_DEVIATION 11.2 • n=206 Participants
|
|
Average Diastolic blood pressure
|
74.0 mmHg
STANDARD_DEVIATION 4.1 • n=99 Participants
|
79.3 mmHg
STANDARD_DEVIATION 7.1 • n=107 Participants
|
75.4 mmHg
STANDARD_DEVIATION 5.3 • n=206 Participants
|
|
Average Heart Rate
|
83.1 bpm
STANDARD_DEVIATION 10.9 • n=99 Participants
|
76.5 bpm
STANDARD_DEVIATION 13.3 • n=107 Participants
|
81.3 bpm
STANDARD_DEVIATION 11.3 • n=206 Participants
|
|
Total Cholesterol
|
175.4 mg/dL
STANDARD_DEVIATION 43.8 • n=99 Participants
|
141.3 mg/dL
STANDARD_DEVIATION 11.4 • n=107 Participants
|
166.1 mg/dL
STANDARD_DEVIATION 40.3 • n=206 Participants
|
|
HDL Cholesterol
|
55.3 mg/dL
STANDARD_DEVIATION 17.6 • n=99 Participants
|
43.3 mg/dL
STANDARD_DEVIATION 4.0 • n=107 Participants
|
52.0 mg/dL
STANDARD_DEVIATION 15.8 • n=206 Participants
|
|
Triglycerides
|
192.8 mg/dL
STANDARD_DEVIATION 184.5 • n=99 Participants
|
111.0 mg/dL
STANDARD_DEVIATION 57.4 • n=107 Participants
|
170.5 mg/dL
STANDARD_DEVIATION 161.1 • n=206 Participants
|
|
LDL Cholesterol
|
80.6 mg/dL
STANDARD_DEVIATION 15.5 • n=99 Participants
|
78.3 mg/dL
STANDARD_DEVIATION 8.4 • n=107 Participants
|
79.9 mg/dL
STANDARD_DEVIATION 13.3 • n=206 Participants
|
|
Estimated glomerular filtration rate (eGFR)
|
93.0 mL/min/1.73m2
STANDARD_DEVIATION 15.4 • n=99 Participants
|
89.0 mL/min/1.73m2
STANDARD_DEVIATION 5.6 • n=107 Participants
|
91.9 mL/min/1.73m2
STANDARD_DEVIATION 13.3 • n=206 Participants
|
|
B-blockers
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Calcium antagonists
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
angiotensin converting enzyme (ACE)-I/ angiotensin receptor blocker (ARB)
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Statins
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Diuretics
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Metformin
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sulfonylurea
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Glucagon-like peptide-1 (GLP-1)/Dipeptidyl Peptidase-4 (DPP-4)
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Insulin
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksPopulation: Out of the 8 participants who completed the study, 5 Participants had full data analyzed for this outcome measure, where three participants had the ABPM missing, so they were excluded from the final data analysis.
Blood pressure was measured at baseline with a 24 hour ambulatory blood pressure machine (ABPM), and again after 6 weeks of treatment.
Outcome measures
| Measure |
Dapagliflozin
n=5 Participants
Dapagliflozin: 5mg pill taken once daily
|
Placebo
n=5 Participants
Placebo: 5mg pill taken once daily
|
|---|---|---|
|
Change in Blood Pressure From Baseline to 6 Weeks Measured by ABPM
Systolic Blood pressure
|
-10.72 mmHg
Standard Deviation 6.17
|
1.94 mmHg
Standard Deviation 17.01
|
|
Change in Blood Pressure From Baseline to 6 Weeks Measured by ABPM
Diastolic blood pressure
|
-3.34 mmHg
Standard Deviation 4.2
|
1.56 mmHg
Standard Deviation 15.05
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksPopulation: Out of the 8 participants who completed the study, 5 Participants had full data analyzed for this outcome measure, where three participants had the AGT data missing, so they were excluded from the final data analysis.
Urinary Angiotensinogen (AGT) was measured through the collection of 24 hour urine at baseline and again after 6 weeks of treatment. Angiotensinogen was normalized to creatinine.
Outcome measures
| Measure |
Dapagliflozin
n=5 Participants
Dapagliflozin: 5mg pill taken once daily
|
Placebo
n=5 Participants
Placebo: 5mg pill taken once daily
|
|---|---|---|
|
Change in Urinary AGT Levels From Baseline to 6 Weeks
|
53.85 ng/mg
Standard Deviation 98.79
|
39.69 ng/mg
Standard Deviation 58.37
|
Adverse Events
Dapagliflozin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place