The aim of this study is to investigate the beneficial role of ertugliflozin, a new SGLT2 inhibitor, in cardiac function via measuring GLS as well as other hemodynamic factors using echocardiogram in patients with T2D and HF, who are not controlled with oral antidiabetic medications including DPP4 inhibitors.
This study is a phase 3, randomized, double-blind, active-competitor, parallel-group study that is anticipated to enroll 120 patients. Patients taking metformin and/or DPP4 inhibitors as per local label for ≥12 weeks without a dose adjustment before enrollment will be eligible for screening. All patients will have a screening period comprised of an up to 2-week screening phase prior to randomization. In order to qualify for randomization, patients must demonstrate compliance based upon pill count (80%) and discretion of the investigators during the Run-in phase. Glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) will be masked to patients after randomization. To prevent partial unblinding, urinary glucose excretion (UGE) results will be masked to patients. Urine glucose, albumin, calcium, and creatinine will be measured separately on-site visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
102
Ertugliflozin as add-on to Metformin and/or DPP4 inhibitors in patients with inadequately controlled type 2 diabetes
Placebo as add-on to Metformin and/or DPP4 inhibitors in patients with inadequately controlled type 2 diabetes
Seoul National University Bundang Hospita;
Seongnam-si, Gyeonggi-do, South Korea
Left Ventricular Global Longitudinal Strain (LVGLS)
Change in LVGLS after 24 weeks of treatment
Time frame: Baseline, Week 24
Left Ventricular Mass Index (LVMI)
Change in LVMI after 24 weeks of treatment
Time frame: Baseline, Week 24
Left Ventricular Ejection Fraction (LVEF)
Change in LVEF after 24 weeks of treatment
Time frame: Baseline, Week 24
E/e' Ratio
Change in E/e' ratio after 24 weeks of treatment
Time frame: Baseline, Week 24
Left Atrium Ventricular Index (LAVI)
Change in LVVI after 24 weeks of treatment
Time frame: Baseline, Week 24
Left Ventricular End-diastolic Volume (LVEDV)
Change in LVEDV after 24 weeks of treatment
Time frame: Baseline, Week 24
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