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

Primary Purpose

Diabetes Mellitus, Coronary Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Empagliflozin
Sitagliptin
Sponsored by
CHEOL WHAN LEE, M.D., Ph.D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Empagliflozin, Sitagliptin, Myocardial perfusion reserve

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with Empagliflozin

Patients with Sitagliptin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Absolute change in regional MPR index
Absolute change in global MPR index

Full Information

First Posted
June 28, 2017
Last Updated
August 5, 2019
Sponsor
CHEOL WHAN LEE, M.D., Ph.D
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1. Study Identification

Unique Protocol Identification Number
NCT03208465
Brief Title
Empagliflozin Versus Sitagliptin Therapy for Improvement of Myocardial Perfusion Reserve in Diabetic Patients With Coronary Artery Disease
Acronym
ELITE
Official Title
Empagliflozin Versus Sitagliptin Therapy for Improvement of Myocardial Perfusion Reserve in Diabetic Patients With Coronary Artery disease_ELITE Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 7, 2017 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CHEOL WHAN LEE, M.D., Ph.D

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Coronary Disease
Keywords
Empagliflozin, Sitagliptin, Myocardial perfusion reserve

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with Empagliflozin
Arm Type
Experimental
Arm Title
Patients with Sitagliptin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Intervention Description
In empagliflozin group, patients will be prescribed empagliflozin 10mg/day.
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Description
In sitagliptin group, patients will be prescribed sitagliptin 100mg/day.
Primary Outcome Measure Information:
Title
Percent change in global myocardial perfusion reserve (MPR) index
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percent change in regional MPR index
Description
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.
Time Frame
6 months
Title
Absolute change in regional MPR index
Time Frame
6 months
Title
Absolute change in global MPR index
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34397987
Citation
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.
Results Reference
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Empagliflozin Versus Sitagliptin Therapy for Improvement of Myocardial Perfusion Reserve in Diabetic Patients With Coronary Artery Disease

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