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

Diabetes Mellitus Clinical Trial

— ELITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208465
• Other study ID #: AMCCV2016-20
• Status: Completed
• Phase: Phase 4
• Start date: August 7, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

Drug:
• Empagliflozin
In empagliflozin group, patients will be prescribed empagliflozin 10mg/day.
• Sitagliptin
In sitagliptin group, patients will be prescribed sitagliptin 100mg/day.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CHEOL WHAN LEE, M.D., Ph.D

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Absolute change in regional MPR index		6 months
Secondary	Absolute change in global MPR index		6 months