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Dapagliflozin Effects on Epicardial Fat

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dapagliflozin
Metformin
Placebo
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring epicardial fat, diabetes, dapagliflozin

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dapagliflozin and Metformin Group

Metformin and Placebo Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 4, 2014
Last Updated
January 27, 2021
Sponsor
University of Miami
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02235298
Brief Title
Dapagliflozin Effects on Epicardial Fat
Official Title
Effects of Dapagliflozin on Epicardial Fat in Subjects With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
September 10, 2020 (Actual)
Study Completion Date
September 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
AstraZeneca

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
epicardial fat, diabetes, dapagliflozin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin and Metformin Group
Arm Type
Experimental
Arm Description
Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.
Arm Title
Metformin and Placebo Group
Arm Type
Active Comparator
Arm Description
Participants in this group will receive Metformin and Placebo for 6 months.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Other Intervention Name(s)
Farxiga
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pill taken once daily to mimic Dapagliflozin
Primary Outcome Measure Information:
Title
Epicardial Fat Thickness
Description
Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks
Time Frame
At Baseline, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Left Ventricular Mass (LVM)
Description
LVM will be measured in g/m^2 by treating physician using echocardiography at baseline, Week 12 and Week 24
Time Frame
At Baseline, Week 12 and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianluca Iacobellis, MD, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dapagliflozin Effects on Epicardial Fat

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