Empagliflozin Versus Sitagliptin Therapy for Improvement of Myocardial Perfusion Reserve in Diabetic Patients With Coronary Artery Disease

• Status: Completed
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial evaluates the effects of Empagliflozin versus Sitagliptin, in addition to standard of care, on global myocardial perfusion reserve using dynamic single-photon emission computed tomography (SPECT) images.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CHEOL WHAN LEE, M.D., Ph.D
• Treatments: Empagliflozin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Men or women at least 19 years of age

• Type 2 diabetes mellitus

• Stable coronary artery disease

• Global myocardial perfusion reserve (MPR) index < 2.5

• The patient or guardian agrees to the study protocol and the schedule of clinical and dynamic SPECT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

• Contraindications to empagliflozin, Sitagliptin

• DPP4 inhibitors or Sodium-glucose cotransporter-2(SGLT2) inhibitors within the previous 4 weeks

• Insulin requiring diabetes

• Poor glucose control (HbA1C>10 %)

• Acute coronary syndrome

• Stent placement within the previous 6 months

• Previous coronary artery bypass graft surgery within the previous 6 months

• Planned revascularization within 6 months

• Heart failure requiring loop diuretics

• Severe left ventricular hypertrophy (left ventricular septal wall thickness > 13mm)

• Significant renal disease manifested by creatinine clearance of < 30 ml/min)

• Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alanine transaminase or Aspartate Aminotransferase > 3 times upper limit of normal)

• Radiopaque material implanted in the chest wall (metal, silicone, etc.)

• Contraindication to adenosine stress test

• Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.

• Patient's pregnant or breast-feeding or child-bearing potential

• Expected life expectancy < 1 year

• Unwillingness or inability to comply with the procedures described in this protocol