Dapagliflozin Effects on Epicardial Fat

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235298
• Other study ID #: 20140671
• Status: Completed
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: September 10, 2020

Study information

• Verified date: January 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 10, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• 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
• Placebo
Placebo pill taken once daily to mimic Dapagliflozin

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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