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Completed

NCT Number: NCT02235298

Dapagliflozin Effects on Epicardial Fat

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

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin

Drug

5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.

Other names: Farxiga

metformin

Drug

500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL

Placebo

Drug

Placebo pill taken once daily to mimic Dapagliflozin

Primary outcomes

  1. Epicardial Fat Thickness

    Time frame: At Baseline, 12 weeks, 24 weeks

    Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks

Secondary outcomes

  1. Left Ventricular Mass (LVM)

    Time frame: At Baseline, Week 12 and Week 24

    LVM will be measured in g/m^2 by treating physician using echocardiography at baseline, Week 12 and Week 24

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 9, 2014
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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