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Dapagliflozin Effects on Epicardial Fat

NCT02235298 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-02-16

Study results available
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Summary

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

Conditions

Interventions

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.

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Gianluca Iacobellis, MD, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2020-09-10
Completion
2020-09-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02235298 on ClinicalTrials.gov