Type 2 Diabetes
Conditions
Interventions
The interventions of the study consist of a low-sodium diet versus a high
sodium diet and a placebo versus ertugliflozin 15 once daily
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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
Exclusion criteria
Exclusion criteria: • History of unstable or rapidly progressing renal disease • Estimated GFR 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 (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed