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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how salt intake affects the way ertugliflozin works in people with type 2 diabetes. It looks at kidney filtering, oxygen levels in the kidneys, and blood flow, comparing the drug with a placebo (a treatment with no active drug). It is for adults ages 18–85 who are overweight or obese and meet certain kidney health rules.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have diagnosed type 2 diabetes and be age 18–85. People of all races and ethnic groups may join.
  • Have an HbA1c of 6.5–10%. This blood test shows average blood sugar over time.
  • Have a BMI over 25, a measure of weight compared with height.
  • Women must have gone through menopause, with no periods for over 1 year. A hormone test may be needed if this is unclear.
  • Have an eGFR of 60–90, a measure of kidney filtering, and a UACR below 30 mg/mmol, a measure of protein in urine.
  • Have a starting sodium (salt) intake below 200 mmol per day.
  • Take a steady dose of diabetes medicine. If you have high blood pressure, take a steady dose of a RAS inhibitor, or another blood pressure medicine if you cannot tolerate it.
  • Be able to give signed, dated written consent before any study tests or procedures.

Who can't join

  • Have unstable or quickly worsening kidney disease, kidney filtering outside the allowed range, urine protein above the limit, a current urinary tract infection, or active kidney inflammation.
  • Use certain medicines: SGLT2 inhibitors, TZDs, or GLP-1 medicines for diabetes; steroids; medicines that weaken the immune system; medicines for infections; or chemotherapy. Some mental health medicines must be at steady doses. Water pills must be stopped during the study.
  • Regularly use NSAIDs, pain medicines such as ibuprofen. Occasional use of 1–2 tablets is allowed for short-term pain, but none may be taken within 2 weeks before kidney testing.
  • Had diabetic ketoacidosis, a dangerous acid buildup related to diabetes, needing medical care within 1 month before screening.
  • Have a recent history, within 6 months, of certain heart or blood vessel problems, including sudden heart problems, heart failure in classes II–IV, stroke, or a brief stroke-like episode.
  • Have severe liver problems or liver blood tests over 3 times the normal upper limit. Have active cancer or still receive cancer treatment other than hormone treatment.
  • Have a history of or current severe mental illness, substance abuse (including more than 4 alcohol units daily), or an allergy to a study substance.
  • Work directly on the study at the study site, are an immediate family member of such staff, or cannot understand the study or give consent.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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) * 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 Criteria: * 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 * 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

Study sites (1)

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