Diabetes MellitusPhase 4DESIGNNCT05727579
DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study
A Phase 4 study testing Salt-Diet and/or Ertugliflozin and Ertugliflozin 15 mg in people with Diabetes Mellitus and Diabetic Kidney Disease, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
SGLT2 inhibitors such as ertugliflozin improve blood pressure and kidney outcomes in people living with diabetes through incompletely understood mechanisms, however, not all patients treated with SGLT2 inhibition have improved outcomes. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Diabetic Kidney Disease, Hypertension
- What is being tested?
- Salt-Diet and/or Ertugliflozin and Ertugliflozin 15 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Jul 2023to 30 Nov 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with previously diagnosed T2DM according to American Diabetes Association (ADA) criteria
- HbA1c 6.5-10%
- Age 35-80 years of age
- Overweight or obese with BMI: >25 kg/m2
- We will make every effort to enrol participants of all races/ethnicities."
- Both sexes (females must be post-menopausal; no menses >1 year; in case of doubt, Follicle-Stimulating Hormone (FSH) will be determined with cut-off defined as >31 U/L)
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- Ability to provide signed and dated, written informed consent prior to any study procedures
- Estimated GFR 60-90 ml/min/1.73m2 by CKD-EPI matching the eGFR range of most participants in VERTIS-CV
- Sodium intake at baseline < 200 mmol/day
- UACR < 30 mg/mmol
- All participants need to be on a stable dose of Diabetes medication, including Metformin, SU, insulin
- All participants need to be on a stable dose of RAS inhibition
Who cannot join
- History of unstable or rapidly progressing renal disease
- Estimated GFR <60 mL/min/1.73m2 or eGFR > 90 mL/min/1.73m2 determined by CKD-EPI
- UACR > 30 mg/mmol
- Current/chronic use of the following medication: SGLT2 inhibitors, TZD, GLP-1RA, glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs). Subjects on diuretics will only be excluded when these drugs cannot be stopped for the duration of the study.
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e. sports injury, headache or back ache). However, no such drug can be taken within a timeframe of 2 weeks prior to renal testing
- History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalization) within 1 month prior to the Screening visit.
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- Current urinary tract infection and active nephritis
- Recent (<6 months) history of cardiovascular disease, including:
- Acute coronary syndrome
- Chronic heart failure (New York Heart Association grade II-IV)
- Stroke or transient ischemic neurologic disorder
- Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
- History of or actual malignancy (except basal cell carcinoma)
- History of or actual severe mental disease
- Substance abuse (alcohol: defined as >4 units/day)
- Allergy to any of the agents used in the study
- Individuals who are investigator site personnel, directly affiliated with the study, or are immediate (spouse, parent, child, or sibling, whether biological or legally adopted) family of investigator site personnel directly affiliated with the study
- Inability to understand the study protocol or give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study, a Randomized, Placebo-controlled, Cross-over Study With Ertugliflozin in People With Type 2 Diabetes
SGLT2 inhibitors such as ertugliflozin improve blood pressure and kidney outcomes in people living with diabetes through incompletely understood mechanisms, however, not all patients treated with SGLT2 inhibition have improved outcomes. Changes in kidney sodium handling is among the mechanisms by which SGLT2 inhibition may reduce blood pressure and drive beneficial kidney outcomes. This process is heavily dependent on daily sodium intake by patients receiving SGLT2 inhibitor treatment. In this study, the effect of daily sodium intake on SGLT2-inhibitor induced physiological effect is studied, including blood pressure regulation and kidney physiology.
- Conditions
- Diabetes Mellitus, Diabetic Kidney Disease, Hypertension
- Being tested
- Salt-Diet and/or Ertugliflozin, Ertugliflozin 15 mg
- Medical subject headings
- Diabetes Mellitus, Diabetic Nephropathies, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt-Diet and/or ErtugliflozinOther
The interventions consist of an determined amount of dietary sodium intake in combination with either Ertugliflozin 15mg once daily or placebo
Ertugliflozin 15 mgDrug
SGLT2i
| Study group | Role | What they receive |
|---|---|---|
| moderate-sodium diet; placebo | Placebo comparator | Not described Receives: Other: Salt-Diet and/or Ertugliflozin |
| moderate-sodium diet; ertugliflozin 15 once daily | Active comparator | Not described Receives: Other: Salt-Diet and/or Ertugliflozin; Drug: Ertugliflozin 15 mg |
| high-sodium diet; placebo | Placebo comparator | Not described Receives: Other: Salt-Diet and/or Ertugliflozin |
| High-sodium diet; ertugliflozin 15 mg once daily | Active comparator | Not described Receives: Other: Salt-Diet and/or Ertugliflozin; Drug: Ertugliflozin 15 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Investigate the Modifying Effect of Sodium Intake on Ertugliflozin on Blood Pressure
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start3 Jul 2023
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- While the treatment by ertugliflozin or placebo will be blinded, the sodium interventions are open-label.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, University of Colorado, Denver
- Responsible party
- Principal investigator, Daniel van Raalte, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727579
- Sponsor's protocol ID
- DC2022ERTU
- Acronym
- DESIGN
- Status last verified
- Mar 2026
- First submitted
- 24 Jan 2023
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study, a Randomized, Placebo-controlled, Cross-over Study With Ertugliflozin in People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05727579
- Acronym / sponsor ID
- DESIGN / DC2022ERTU
- Conditions
- Diabetes Mellitus, Diabetic Kidney Disease, Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, University of Colorado, Denver
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Posted 15 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SGLT2 inhibitors such as ertugliflozin improve blood pressure and kidney outcomes in people living with diabetes through incompletely understood mechanisms, however, not all patients treated with SGLT2 inhibition have improved outcomes. Changes in kidney sodium handling is among the mechanisms by which SGLT2 inhibition may reduce blood pressure and drive beneficial kidney outcomes. This process is heavily dependent on daily sodium intake by patients receiving SGLT2 inhibitor treatment. In this study, the effect of daily sodium intake on SGLT2-inhibitor induced physiological effect is studied, including blood pressure regulation and kidney physiology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- While the treatment by ertugliflozin or placebo will be blinded, the sodium interventions are open-label.
| Arm | Type | Receives |
|---|---|---|
| moderate-sodium diet; placebo | Placebo comparator | Other: Salt-Diet and/or Ertugliflozin |
| moderate-sodium diet; ertugliflozin 15 once daily | Active comparator | Other: Salt-Diet and/or Ertugliflozin, Drug: Ertugliflozin 15 mg |
| high-sodium diet; placebo | Placebo comparator | Other: Salt-Diet and/or Ertugliflozin |
| High-sodium diet; ertugliflozin 15 mg once daily | Active comparator | Other: Salt-Diet and/or Ertugliflozin, Drug: Ertugliflozin 15 mg |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults with previously diagnosed T2DM according to American Diabetes Association (ADA) criteria
- HbA1c 6.5-10%
- Age 35-80 years of age
- Overweight or obese with BMI: >25 kg/m2
- We will make every effort to enrol participants of all races/ethnicities."
Key exclusion criteria (18 listed)
- History of unstable or rapidly progressing renal disease
- Estimated GFR <60 mL/min/1.73m2 or eGFR > 90 mL/min/1.73m2 determined by CKD-EPI
- UACR > 30 mg/mmol
- Current/chronic use of the following medication: SGLT2 inhibitors, TZD, GLP-1RA, glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs). Subjects on diuretics will only be excluded when these drugs cannot be stopped for the duration of the study.
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e. sports injury, headache or back ache). However, no such drug can be taken within a timeframe of 2 weeks prior to renal testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salt-Diet and/or ErtugliflozinThe interventions consist of an determined amount of dietary sodium intake in combination with either Ertugliflozin 15mg once daily or placebo | Other | High-sodium diet; ertugliflozin 15 mg once daily, high-sodium diet; placebo, moderate-sodium diet; ertugliflozin 15 once daily, moderate-sodium diet; placebo |
| Ertugliflozin 15 mgSGLT2i | Drug | High-sodium diet; ertugliflozin 15 mg once daily, moderate-sodium diet; ertugliflozin 15 once daily |
Primary outcome
To Investigate the Modifying Effect of Sodium Intake on Ertugliflozin on Blood Pressure
Time frame: 24 weeks
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salt-Diet and/or Ertugliflozin and Ertugliflozin 15 mg in people with Diabetes Mellitus and Diabetic Kidney Disease, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Investigate the Modifying Effect of Sodium Intake on Ertugliflozin on Blood Pressure (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.