Dapagliflozin Effects on Epicardial Fat

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Dapagliflozin; Drug: Metformin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epicardial Fat Thickness	Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks	At Baseline, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left Ventricular Mass (LVM)	LVM will be measured in g/m^2 by treating physician using echocardiography at baseline, Week 12 and Week 24	At Baseline, Week 12 and Week 24

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Gianluca Iacobellis, MD, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 10, 2020
• Study Completion (Actual): September 10, 2020

Study Registration Dates

• First Submitted: September 4, 2014
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (Estimate): September 9, 2014

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: diabetes; dapagliflozin; epicardial fat
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin; Metformin
• Other Study ID Numbers: 20140671

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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