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

Study Overview
=================
Brief 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.

Official Title
-----------------
Empagliflozin Versus Sitagliptin Therapy for Improvement of Myocardial Perfusion Reserve in Diabetic Patients With Coronary Artery disease_ELITE Trial

Conditions
-----------------
Diabetes Mellitus, Coronary Disease

Intervention / Treatment
-----------------
* Drug: Empagliflozin
* Drug: Sitagliptin


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Empagliflozin<br> | Drug: Empagliflozin<br>* In empagliflozin group, patients will be prescribed empagliflozin 10mg/day.<br>|
| Active Comparator: Patients with Sitagliptin<br> | Drug: Sitagliptin<br>* In sitagliptin group, patients will be prescribed sitagliptin 100mg/day.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in global myocardial perfusion reserve (MPR) index | Percent change in global myocardial perfusion reserve (MPR) index defined as (global MPR index at 6 months - global MPR index at baseline)/(global MPR index at baseline)x100. MPR index=stress myocardial flow/rest myocardial flow | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in regional MPR index | Percent change in regional MPR index defined as (regional MPR index at 6 months - regional MPR index at baseline)/(regional MPR index at baseline)x100. | 6 months | 
| Absolute change in regional MPR index |  | 6 months | 
| Absolute change in global MPR index |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Empagliflozin, Sitagliptin, Myocardial perfusion reserve