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The DESIGN Study: Ertugliflozin and Salt Intake in Type 2 Diabetes

This study, called the DESIGN Study, is looking at how a medication called ertugliflozin affects people with Type 2 Diabetes, and how this might change depending on how much salt they eat. Ertugliflozin is a type of drug (SGLT2 inhibitor) that helps protect the heart and kidneys, but we don't fully understand how it works or if salt intake changes its effects. This study will compare ertugliflozin to a placebo (an inactive pill) and also compare a low-salt diet to a high-salt diet. We are looking for adults aged 18 to 85 with Type 2 Diabetes, an HbA1c between 6.5-10%, and a BMI over 25. The main goal is to measure blood pressure after 7 months to see how these different treatments affect it. The study is currently recruiting participants.

Study design
This is a randomized, placebo-controlled, cross-over study involving 34 participants with Type 2 Diabetes.
What's involved
The primary endpoint, blood pressure, is measured at 7 months. Other specific visits or procedures are not detailed.
Compensation
Not stated in the trial record.
Follow-up
Blood pressure is measured at 7 months, which indicates the study duration for this primary outcome.

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NCT06983054

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

Recruiting
PHASE4Ages 18–85InterventionalTreatment
Amsterdam UMC, location VUmc
~34 participants
Updated 2025-05-21 on ClinicalTrials.gov
What's tested:ertugliflozinelow salt dietplacebohigh salt diet

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Blood pressure
Measured over 7 months

Conditions

Type 2 Diabetes

Explore related trials

Type 2 Diabetes Mellitus

Where it's being run

2 sites across 2 states
Colorado1
Netherlands1

Who to contact

Jessica Kendrick, Prof.
[email protected]
303-724-4837
Email the study team

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Eligibility criteria

Inclusion

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)
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.

Exclusion

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.
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

What this trial measures

  • Blood pressure7 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.