Type 2 DiabetesPhase 4DESIGNNCT06983054
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
A Phase 4 study testing ertugliflozine, low salt diet and high salt diet in people with Type 2 Diabetes, run by Amsterdam UMC, location VUmc at 2 sites in 2 countries.
Trial summary
SGLT2 inhibitors have demonstrated to mitigate cardiorenal risk in people with type 2 diabetes and are likely to play an increasingly large role in the treatment of patients with diabetes, chronic kidney disease and hypertension. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- ertugliflozine, low salt diet and high salt diet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Jul 2023to Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 85 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 18 - 85 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, DPP4-inhibitors, or insulin.
- Participants suffering from hypertension need to be on a stable dose of RAS inhibitors. In case RAS inhibition is not tolerated, the participant should to be on a stable dose of other antihypertensive treatment.
Who cannot join
- History of unstable or rapidly progressing renal disease NL80772.029.22 / DC2022ERTU DESIGN Protocol DESIGN, Study NO. 2022.0737 Version 5.0dd22-02-2024 14 of 45
- 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 Participants should be on a stable dose of 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
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- History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalization) within 1 month prior to the Screening visit.
- 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
- Active malignancy. History of malignancy is allowed unless the participant still has active treatment other than hormonal therapy.• 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
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Childrens hospital colorado
Denver, Colorado, 80045
Jessica Kendrick, Prof., 303-724-4837, Jessica.Kendrick@cuanschutz.edu
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Daniel H van Raalte, Prof. Dr., +31-20-4440534, d.vanraalte@amsterdamumc.nl
About this study
SGLT2 inhibitors have demonstrated to mitigate cardiorenal risk in people with type 2 diabetes and are likely to play an increasingly large role in the treatment of patients with diabetes, chronic kidney disease and hypertension. Yet the underlying mechanisms of its protective effects are incompletely understood and the salutary effect may be altered by dietary factors such as sodium intake. Therefore, carefully designed mechanistic trials are needed to better understand the interplay between ertugliflozin and salt intake and to potentially modify salt intake to maximize treatment response. In addition, the study could contribute to hypotheses concerning the effects of SGLT2 inhibitors in combination with other drugs that affect sodium homeostasis and could help to explain the differences in kidney outcomes observed in (outcome) trials, which include different ethnicities with potential differences in dietary habits.
- Conditions
- Type 2 Diabetes
- Being tested
- ertugliflozine, low salt diet, placebo, high salt diet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ertugliflozineDrug
SGLT2i versus placebo
low salt dietBehavioural
comparing low salt versus high salt diet
placeboDrug
placebo tablet
high salt dietBehavioural
high salt diet
| Study group | Role | What they receive |
|---|---|---|
| Low salt diet with SGLT2i | Active comparator | 10 days of SGLT2i treatment during 20 days of low salt diet Receives: Drug: ertugliflozine; Behavioral: low salt diet |
| Low salt diet with placebo | Placebo comparator | 10 days of placebo during 20 days of low salt diet Receives: Behavioral: low salt diet; Drug: placebo |
| High salt diet with SGLT2i | Active comparator | 10 days of SGTL2i during 20 days of high salt diet. Receives: Drug: ertugliflozine; Behavioral: high salt diet |
| High salt diet with placebo | Placebo comparator | 10 days of placebo during 20 days of high salt diet. Receives: Drug: placebo; Behavioral: high salt diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 7 months
Secondary outcomes (1)
Blood pressure
To investigate the efficacy of ertugliflozin 15 mg daily, versus placebo, in overweight/obese adults with type 2 diabetes to reduce the hypertensive effects of a high-sodium diet (250 mmol per day) versus 24-hour blood pressure measurement during participant's normal diet (170 mmol/per day) obtained at screening visit
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start25 Jul 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Principal investigator, Daniel van Raalte, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983054
- Sponsor's protocol ID
- NL80772.029.22
- Other IDs
- 2023-510257-42-01, 2021-005474-25, 2023
- Acronym
- DESIGN
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 21 May 2025
- Results posted
- 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 21 May 2025. 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
- NCT06983054
- Acronym / sponsor ID
- DESIGN / NL80772.029.22
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SGLT2 inhibitors have demonstrated to mitigate cardiorenal risk in people with type 2 diabetes and are likely to play an increasingly large role in the treatment of patients with diabetes, chronic kidney disease and hypertension. Yet the underlying mechanisms of its protective effects are incompletely understood and the salutary effect may be altered by dietary factors such as sodium intake. Therefore, carefully designed mechanistic trials are needed to better understand the interplay between ertugliflozin and salt intake and to potentially modify salt intake to maximize treatment response. In addition, the study could contribute to hypotheses concerning the effects of SGLT2 inhibitors in combination with other drugs that affect sodium homeostasis and could help to explain the differences in kidney outcomes observed in (outcome) trials, which include different ethnicities with potential differences in dietary habits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low salt diet with SGLT2i | Active comparator | Drug: ertugliflozine, Behavioral: low salt diet10 days of SGLT2i treatment during 20 days of low salt diet |
| Low salt diet with placebo | Placebo comparator | Behavioral: low salt diet, Drug: placebo10 days of placebo during 20 days of low salt diet |
| High salt diet with SGLT2i | Active comparator | Drug: ertugliflozine, Behavioral: high salt diet10 days of SGTL2i during 20 days of high salt diet. |
| High salt diet with placebo | Placebo comparator | Drug: placebo, Behavioral: high salt diet10 days of placebo during 20 days of high salt diet. |
Who may qualify
- Ages
- 18 to 85 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 18 - 85 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 NL80772.029.22 / DC2022ERTU DESIGN Protocol DESIGN, Study NO. 2022.0737 Version 5.0dd22-02-2024 14 of 45
- 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.
- Current urinary tract infection and active nephritis
- Recent (<6 months) history of cardiovascular disease, including:
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 |
|---|---|---|
| ertugliflozineSGLT2i versus placebo | Drug | High salt diet with SGLT2i, Low salt diet with SGLT2i |
| low salt dietcomparing low salt versus high salt diet | Behavioural | Low salt diet with SGLT2i, Low salt diet with placebo |
| placeboplacebo tablet | Drug | High salt diet with placebo, Low salt diet with placebo |
| high salt diethigh salt diet | Behavioural | High salt diet with SGLT2i, High salt diet with placebo |
Primary outcome
Blood pressure
Time frame: 7 months
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.
1 secondary outcome
Blood pressure
Time frame: 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ertugliflozine, low salt diet and high salt diet in people with Type 2 Diabetes, run by Amsterdam UMC, location VUmc at 2 sites in 2 countries.
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: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 7 months). 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 21 May 2025.