Effect of Ertugliflozin on Cardiac Function in Diabetes

Inclusion Criteria:

• Patients with T2D taking oral antidiabetic medications (metformin and/or DPP4inhibitors) except SGLT2 inhibitors for at least 12 weeks without a dose adjustmentbefore enrollment.

• eGFR ≥ 45 mL/min/1.73 m2.

• Stage B HF identified on the basis of either structural or functional markers.

Exclusion Criteria:

• Type 1 diabetes mellitus

• At the time of screening age <20 years

• HbA1c <7% or HbA1c >9.5% at Screening

• FPG >15 mmol/L (270 mg/dL) measured by the laboratory at Screening (Visit 1), andconfirmed (>15 mmol/L [>270 mg/dL]) by a repeat test before randomization

• Treated with insulin and/or GLP-1R agonist within 12 weeks preceding the ScreeningVisit.

• Women of childbearing potential with no effective contraceptive method

• History of gastric surgery including history of gastric banding within 3 yearsbefore the Screening Visit

• History of diabetic ketoacidosis or nonketotic hyperosmolar coma prior to theScreening Visit

• Mean blood pressure after 3 separate measurements >180 mmHg in systolic bloodpressure (SBP) or >95 mmHg in diastolic blood pressure (DBP)

• Patients with current or prior symptoms of HF.

• Patients with severe anemia, severe respiratory, hepatic, neurological, psychiatricdisorders or active malignant tumor or other major systemic disease or patients withshort life expectancy making implementation of the protocol or interpretation of thestudy results difficult

• Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limitof the normal laboratory range (ULN)

• Total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome)

• Use of systemic glucocorticoids (excluding topical or ophthalmic, application orinhaled forms) for more than 10 consecutive days within 90 days prior to theScreening Visit

• Patient who has taken other investigational drugs or prohibited therapy for thisstudy within 3 months