Overview

Dapagliflozin Effects on Epicardial Fat

Status:
Completed
Trial end date:
2020-09-10
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on the fat of the heart.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Miami
Collaborator:
AstraZeneca
Treatments:
Dapagliflozin
Metformin
Criteria
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