Trial Outcomes & Findings for DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study (NCT NCT05727579)
NCT ID: NCT05727579
Last Updated: 2026-04-15
Results Overview
To investigate the modifying effects of WHO-recommended sodium intake (90 mmol per day) vs. high sodium intake (targeted at 250 mmol per day) on the effect of ertugliflozin 15 mg daily, versus placebo, on 24-hour blood pressure in overweight/obese adults with type 2 diabetes
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
24 weeks
Results posted on
2026-04-15
Participant Flow
Of 61 individuals screened, 41 were enrolled. The required sample size was 34 participants; additional participants were enrolled to account for anticipated dropouts.
Participant milestones
| Measure |
B - A - D - C
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
B - D - C - A
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
C - A - B - D
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
C - B - D - A
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
D - A - B - C
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
D - A - C - B
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
A - B - C - D
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
A - C - D - B
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
6
|
5
|
4
|
5
|
6
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
6
|
4
|
3
|
4
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
B - A - D - C
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
B - D - C - A
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
C - A - B - D
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
C - B - D - A
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
D - A - B - C
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
D - A - C - B
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
A - B - C - D
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
A - C - D - B
A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day for 20 days) + placebo for 10 days D = high sodium diet ( 250 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days between period washout = 4 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
1
|
1
|
1
|
1
|
Baseline Characteristics
DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study
Baseline characteristics by cohort
| Measure |
Baseline Characteristics
n=34 Participants
In total, 34 participants were included
|
|---|---|
|
Age, Continuous
|
69.9 years
STANDARD_DEVIATION 8.7 • n=193 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=193 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=193 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
|
BMI
|
28.4 kg/m²
n=193 Participants
|
|
Hba1c
|
7.7 % glycated hemoglobin
n=193 Participants
|
|
eGFR
|
80.9 mL/min/1.73 m²
STANDARD_DEVIATION 11.7 • n=193 Participants
|
|
systolic blood pressure
|
131 mmHg
STANDARD_DEVIATION 10 • n=193 Participants
|
|
diastolic blood pressure
|
80 mmHg
STANDARD_DEVIATION 7 • n=193 Participants
|
|
Urinary volume
|
1900 mL
n=193 Participants
|
|
24 hour urinary sodium excretion
|
132.5 mmol
n=193 Participants
|
PRIMARY outcome
Timeframe: 24 weeksTo investigate the modifying effects of WHO-recommended sodium intake (90 mmol per day) vs. high sodium intake (targeted at 250 mmol per day) on the effect of ertugliflozin 15 mg daily, versus placebo, on 24-hour blood pressure in overweight/obese adults with type 2 diabetes
Outcome measures
| Measure |
Moderate Sodium Diet; Placebo
n=34 Participants
Participants adhered to moderate sodium intake for 20 days (aimed at 90 mmols sodium per day) verified by 24 hour urine collection after 10 days. Then participants received placebo for 10 days.
|
Moderate Sodium Diet; Ertugliflozin 15 Once Daily
n=34 Participants
Participants adhered to moderate sodium intake for 20 days (aimed at 90 mmols sodium per day) verified by 24 hour urine collection after 10 days. Then participants received ertugliflozin for 10 days.
|
High-sodium Diet; Placebo
n=34 Participants
Participants adhered to high sodium intake for 20 days (aimed at 250 mmols sodium per day) verified by 24 hour urine collection after 10 days. Then participants received placebo for 10 days.
|
High-sodium Diet; Ertugliflozin 15 mg Once Daily
n=34 Participants
Participants adhered to high sodium intake for 20 days (aimed at 250 mmols sodium per day) verified by 24 hour urine collection after 10 days. Then participants received ertugliflozin for 10 days.
|
|---|---|---|---|---|
|
To Investigate the Modifying Effect of Sodium Intake on Ertugliflozin on Blood Pressure
diastolic blood pressure
|
77 mmHg
Standard Deviation 7.1
|
75 mmHg
Standard Deviation 6.9
|
84 mmHg
Standard Deviation 8.6
|
82 mmHg
Standard Deviation 7.7
|
|
To Investigate the Modifying Effect of Sodium Intake on Ertugliflozin on Blood Pressure
systolic blood pressure
|
125 mmHg
Standard Deviation 8.3
|
121 mmHg
Standard Deviation 8.5
|
138 mmHg
Standard Deviation 13
|
133 mmHg
Standard Deviation 12.3
|
Adverse Events
Moderate-sodium Diet; Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate-sodium Diet; Ertugliflozin 15 Once Daily
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
High-sodium Diet; Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High-sodium Diet; Ertugliflozin 15 mg Once Daily
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Moderate-sodium Diet; Placebo
n=34 participants at risk
Participants adhered to moderate sodium intake for 20 days (aimed at 90 mmols sodium per day) verified by 24 hour urine collection after 10 days. Then participants received placebo for 10 days.
|
Moderate-sodium Diet; Ertugliflozin 15 Once Daily
n=34 participants at risk
Participants adhered to moderate sodium intake for 20 days (aimed at 90 mmols sodium per day) verified by 24 hour urine collection after 10 days. Then participants received ertugliflozin for 10 days.
|
High-sodium Diet; Placebo
n=34 participants at risk
Participants adhered to high sodium intake for 20 days (aimed at 250 mmols sodium per day) verified by 24 hour urine collection after 10 days. Then participants received placebo for 10 days.
|
High-sodium Diet; Ertugliflozin 15 mg Once Daily
n=34 participants at risk
Participants adhered to high sodium intake for 20 days (aimed at 250 mmols sodium per day) verified by 24 hour urine collection after 10 days. Then participants received ertugliflozin for 10 days.
|
|---|---|---|---|---|
|
Infections and infestations
genital infection
|
0.00%
0/34 • From screening until the last day of the 4th intervention period, up to approximately 24 weeks. Each intervention period lasted 20 days, with 4-week washout periods between intervention periods.
All cause mortality risk = 0, and there were no serious adverse events. There were some (not serious) adverse events that occurred on the individual level, so in \<5%, therefore, these were not reported.
|
5.9%
2/34 • Number of events 2 • From screening until the last day of the 4th intervention period, up to approximately 24 weeks. Each intervention period lasted 20 days, with 4-week washout periods between intervention periods.
All cause mortality risk = 0, and there were no serious adverse events. There were some (not serious) adverse events that occurred on the individual level, so in \<5%, therefore, these were not reported.
|
0.00%
0/34 • From screening until the last day of the 4th intervention period, up to approximately 24 weeks. Each intervention period lasted 20 days, with 4-week washout periods between intervention periods.
All cause mortality risk = 0, and there were no serious adverse events. There were some (not serious) adverse events that occurred on the individual level, so in \<5%, therefore, these were not reported.
|
0.00%
0/34 • From screening until the last day of the 4th intervention period, up to approximately 24 weeks. Each intervention period lasted 20 days, with 4-week washout periods between intervention periods.
All cause mortality risk = 0, and there were no serious adverse events. There were some (not serious) adverse events that occurred on the individual level, so in \<5%, therefore, these were not reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place