Dapagliflozin Effects on Epicardial Fat

Effects of Dapagliflozin on Epicardial Fat in Subjects With Type 2 Diabetes

The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on the fat of the heart.

Inclusion Criteria:

• Type 2 diabetes, as defined by ADA criteria
• HbA1c < 8% measured at least 1 week prior to the study
• BMI ≥27 kg/m2
• Pre-treatment with Metformin as monotherapy
• Age > 18 and < 65 years old
• Normal and stable hemodynamic status

Exclusion Criteria:

• Known contra-indications to Farxiga, in accordance with risks and safety information included in the latest updated Prescribing Information
• Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
• Insulin dependent or treated type 2 diabetes
• Current use of other SGLT2 inhibitors, Glucagon Like Peptide -1 (GLP- 1) analogs or Dipeptidyl Peptidase 4 (DPP4) inhibitors
• Glomerular Filtration Rate (GFR) < 60 mL/min/1.73 m2
• Signs or symptoms of hypovolemia
• Patients with poor glycemic control (HbA1c ≥ 8%) will be excluded to maximize long-term patient retention without need
• History of diabetes ketoacidosis
• Patients with active bladder cancer or with a prior history of bladder cancer
• Acute or chronic infective, including genital mycotic infections
• Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure
• Clinical or laboratory evidences of chronic active liver diseases
• Acute or chronic infective diseases
• Cancer or chemotherapy
• Current use of systemic corticosteroids or in the 3 months prior this study
• Known or suspected allergy to Dapagliflozin, excipients, or related products
• Pregnant, breast-feeding or the intention of becoming pregnant
• Females of childbearing potential who are not using adequate contraceptive methods