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Dapagliflozin Effects on Epicardial Fat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02235298
Recruitment Status : Completed
First Posted : September 9, 2014
Results First Posted : February 16, 2021
Last Update Posted : February 16, 2021
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Gianluca Iacobellis, University of Miami

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Dapagliflozin Drug: Metformin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Dapagliflozin on Epicardial Fat in Subjects With Type 2 Diabetes
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 10, 2020
Actual Study Completion Date : September 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dapagliflozin and Metformin Group
Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.
Drug: Dapagliflozin
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 Name: Farxiga

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

Active Comparator: Metformin and Placebo Group
Participants in this group will receive Metformin and Placebo for 6 months.
Drug: Metformin
500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL

Drug: Placebo
Placebo pill taken once daily to mimic Dapagliflozin




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235298


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
AstraZeneca
Investigators
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Principal Investigator: Gianluca Iacobellis, MD, PhD University of Miami
  Study Documents (Full-Text)

Documents provided by Gianluca Iacobellis, University of Miami:
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Responsible Party: Gianluca Iacobellis, Professor of Clinical Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT02235298    
Other Study ID Numbers: 20140671
First Posted: September 9, 2014    Key Record Dates
Results First Posted: February 16, 2021
Last Update Posted: February 16, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gianluca Iacobellis, University of Miami:
epicardial fat
diabetes
dapagliflozin
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Dapagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action