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

NCT03208465 | Completed Phase 4 DMC

• 1 other identifier: AMCCV2016-20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Coronary Disease

Keywords

Empagliflozin; Sitagliptin; Myocardial perfusion reserve

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percent change in regional MPR index

  6 months

• Absolute change in regional MPR index

  6 months

• Absolute change in global MPR index

  6 months

Study Arms (2)

Patients with Empagliflozin

EXPERIMENTAL

Drug: Empagliflozin

Patients with Sitagliptin

ACTIVE COMPARATOR

Drug: Sitagliptin

Interventions

Empagliflozin DRUG

In empagliflozin group, patients will be prescribed empagliflozin 10mg/day.

Patients with Empagliflozin

Sitagliptin DRUG

In sitagliptin group, patients will be prescribed sitagliptin 100mg/day.

Patients with Sitagliptin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHEOL WHAN LEE, M.D., Ph.D: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 34397987 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Coronary Disease

Interventions

empagliflozin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 5, 2017
• Study Start: August 7, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

KR (1)