Status:
COMPLETED
Dapagliflozin Effects on Epicardial Fat
Lead Sponsor:
University of Miami
Collaborating Sponsors:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on the fat of the heart.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02235298
Start Date
September 1 2015
End Date
September 10 2020
Last Update
February 16 2021
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136