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

Phase 4

Completed

• Conditions: Diabetes Mellitus; Coronary Disease
• Interventions: Drug: Empagliflozin; Drug: Sitagliptin

• Registration Number: NCT03208465
• Lead Sponsor: CHEOL WHAN LEE, M.D., Ph.D

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-05
• Study Start: 2017-08-07
• Status Verified: 2019-08
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with Empagliflozin	Empagliflozin	-
Patients with Sitagliptin	Sitagliptin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Absolute change in global MPR index	6 months
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of