Dapagliflozin Effects on Epicardial Fat

University of Miami

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin; Drug: Placebo; Drug: Dapagliflozin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02235298

20140671

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Dapagliflozin and Metformin Group

Experimental group

Description:

Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.

Treatment:

Drug: Dapagliflozin

Drug: Metformin

Metformin and Placebo Group

Active Comparator group

Description:

Participants in this group will receive Metformin and Placebo for 6 months.

Treatment:

Drug: Metformin

Drug: Placebo