Type 2 Diabetes Mellitus
Conditions
Interventions
Trade Name: Steglatro 15 mg film-coated tablets
Product Name: ertugliflozin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ertugliflozin
CAS Number: 1210344-57-2
Current Sponsor code: MK
Sponsors
VUmc – Internal medicine / Diabetes Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adults with previously diagnosed T2DM according to American Diabetes Association (ADA) criteria • • HbA1c 6.5-10% • • Age 35-80 years of age • • Overweight or obese with BMI: >25 kg/m2 • • We will make every effort to enroll 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 =65 years) no F.1.3.1 Number of subjects for this age range 10
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, 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 • History of or actual malignancy (except basal cell carcinoma) • 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 |
|---|---|
| Main Objective: 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 Objective: 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 participant’s normal diet (170 mmol/per day).;Primary end point(s): 24-hr blood pressure;Timepoint(s) of evaluation of this end point: At the end of each of the four study conditions. Every condition lasts 10 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Sodium sensitivity • GFR by iohexol clearance • Hematocrit •Office blood pressure • Kidney oxygenation • Parameters of intrarenal hemodynamic function including ERPF by p-aminohippurate clearance and renal vasculature resistance • RAAS components •Body anthropometrics •Fasting plasma glucose •Albumin excretion rate (24 hour) •24-hr urinary glucose excretion •Urinary and plasma biomarkers ;Timepoint(s) of evaluation of this end point: At the end of each of the four study conditions. Every condition lasts 10 days. | — |
Countries
Netherlands, United States
Contacts
Public ContactPrincipal investigator
VU medical center
Outcome results
None listed