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
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
34 (estimated)
Sponsor
Amsterdam UMC, location VUmc · Other
Who this trial is looking for
This trial is looking for adults with type 2 diabetes to study how salt intake affects a medication called ertugliflozin. Participants will take the medication and be monitored for changes related to their kidney health and blood pressure.
Are You a Good Fit for This Trial?
Must be takingMetforminSUDPP4-inhibitorsInsulin
You may be able to join if
I have been diagnosed with type 2 diabetes.
I am between 18 and 85 years old.
I have a body mass index (BMI) over 25.
My blood sugar (HbA1c) is between 6.5 and 10%.
I have a stable dose of diabetes medication.
I have an estimated kidney function (GFR) between 60 and 90 mL/min.
I have a sodium intake of less than 200 mmol/day.
I can give informed consent.
You may not be able to join if
I have a history of unstable or rapidly progressing kidney disease.
My estimated kidney function (GFR) is below 60 mL/min.
I have a UACR above 30 mg/mmol.
I currently take SGLT2 inhibitors or certain other medications.
I have had diabetic ketoacidosis in the last month.
I have a recent history of cardiovascular disease.
I have severe liver problems.
I have an active cancer.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. There…
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.
Trial Locations
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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 (femal…
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
Contacts
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