NCT02235298

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
5 months until next milestone

Results Posted

Study results publicly available

February 16, 2021

Completed
Last Updated

February 16, 2021

Status Verified

January 1, 2021

Enrollment Period

5 years

First QC Date

September 4, 2014

Results QC Date

January 27, 2021

Last Update Submit

January 27, 2021

Conditions

Type 2 Diabetes

Keywords

epicardial fatdiabetesdapagliflozin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Left Ventricular Mass (LVM)

    At Baseline, Week 12 and Week 24

Study Arms (2)

Dapagliflozin and Metformin Group

EXPERIMENTAL

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

Drug: DapagliflozinDrug: Metformin

Metformin and Placebo Group

ACTIVE COMPARATOR

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

Drug: MetforminDrug: Placebo

Interventions

DapagliflozinDRUG

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.

Also known as: Farxiga
Dapagliflozin and Metformin Group
MetforminDRUG

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

Dapagliflozin and Metformin GroupMetformin and Placebo Group
PlaceboDRUG

Placebo pill taken once daily to mimic Dapagliflozin

Metformin and Placebo Group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

dapagliflozinMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Gianluca Iacobellis, MD
Organization
University of Miami
giacobellis@miami.edu
305-243-3636

Study Officials

  • Gianluca Iacobellis, MD, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Medicine

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 9, 2014

Study Start

September 1, 2015

Primary Completion

September 10, 2020

Study Completion

September 10, 2020

Last Updated

February 16, 2021

Results First Posted

February 16, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)