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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease; Diabetes Mellitus
• Intervention / Treatment: Drug: Empagliflozin; Drug: Sitagliptin

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: CHEOL WHAN LEE, M.D., Ph.D

Publications and helpful links

General Publications

• Oh M, Choi JH, Kim SO, Lee PH, Ahn JM, Lee SW, Moon DH, Lee CW. Comparison of empagliflozin and sitagliptin therapy on myocardial perfusion reserve in diabetic patients with coronary artery disease. Nucl Med Commun. 2021 Sep 1;42(9):972-978. doi: 10.1097/MNM.0000000000001429.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2017
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Empagliflozin; Sitagliptin; Myocardial perfusion reserve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Empagliflozin; Sitagliptin Phosphate
• Other Study ID Numbers: AMCCV2016-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No