Phase 4
Completed N=100
Dapagliflozin Effects on Epicardial Fat
Source: ClinicalTrials.gov NCT02235298 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Epicardial Fat Thickness — 8.6; 8.0; 7.2; 7.4 mm
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on the fat of the heart.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Epicardial Fat Thickness |
8.6; 8.0; 7.2; 7.4; 6.7; 7.5 | — |
| SECONDARY Left Ventricular Mass (LVM) |
129; 130; 127; 128; 122; 122 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes, as defined by ADA criteria
- HbA1c 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
Data sourced from ClinicalTrials.gov (NCT02235298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.