Coronary Disease, Diabetes Mellitus
Conditions
Keywords
Empagliflozin, Sitagliptin, Myocardial perfusion reserve
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.
Interventions
DRUGEmpagliflozin
In empagliflozin group, patients will be prescribed empagliflozin 10mg/day.
DRUGSitagliptin
In sitagliptin group, patients will be prescribed sitagliptin 100mg/day.
Sponsors
CHEOL WHAN LEE, M.D., Ph.D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in global myocardial perfusion reserve (MPR) index | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in regional MPR index | 6 months | 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. |
| Absolute change in regional MPR index | 6 months | — |
| Absolute change in global MPR index | 6 months | — |
Countries
South Korea
Outcome results
None listed