Dapagliflozin Effects on Epicardial Fat

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Dapagliflozin; Drug: Placebo; Drug: Metformin

• Registration Number: NCT02235298
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-09
• Study Start: 2015-09
• Primary Completion: 2020-09-10
• Study Completion: 2020-09-10
• Status Verified: 2021-01
• Results First Submitted: 2021-01-27
• Results First Submitted QC: 2021-01-27
• Last Update Submitted: 2021-01-27
• Results First Posted: 2021-02-16
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin and Placebo Group	Placebo	Participants in this group will receive Metformin and Placebo for 6 months.
Dapagliflozin and Metformin Group	Dapagliflozin	Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.
Dapagliflozin and Metformin Group	Metformin	Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.
Metformin and Placebo Group	Metformin	Participants in this group will receive Metformin and Placebo for 6 months.

Primary Outcome Measures

Name	Time	Method
Epicardial Fat Thickness	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

Name	Time	Method
Left Ventricular Mass (LVM)	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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States