Dapagliflozin Effects on Epicardial Fat

Completed · Phase 4 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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

Key facts

Study ID

NCT02235298

Run by

University of Miami

People needed

100

Starts

2015-09-01

Expected to finish

2020-09-10

Last updated by the study team

2021-02-16

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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