Diabetes MellitusPhase 4ELITENCT03208465
Empagliflozin Versus Sitagliptin Therapy for Improvement of Myocardial Perfusion Reserve in Diabetic Patients With Coronary Artery Disease
A Phase 4 study testing Empagliflozin and Sitagliptin in people with Diabetes Mellitus and Coronary Disease, run by CHEOL WHAN LEE, M.D., Ph.D at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus, Coronary Disease
- What is being tested?
- Empagliflozin and Sitagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Aug 2017to 1 Aug 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Coronary Disease
- Being tested
- Empagliflozin, Sitagliptin
- Keywords
- Empagliflozin, Sitagliptin, Myocardial perfusion reserve
- Medical subject headings
- Diabetes Mellitus, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
In empagliflozin group, patients will be prescribed empagliflozin 10mg/day.
SitagliptinDrug
In sitagliptin group, patients will be prescribed sitagliptin 100mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Empagliflozin | Experimental | Not described Receives: Drug: Empagliflozin |
| Patients with Sitagliptin | Active comparator | Not described Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
Absolute change in regional MPR index
Measured: 6 months
Absolute change in global MPR index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start7 Aug 2017
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHEOL WHAN LEE, M.D., Ph.D
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208465
- Sponsor's protocol ID
- AMCCV2016-20
- Acronym
- ELITE
- Status last verified
- Aug 2019
- First submitted
- 28 Jun 2017
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34397987
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empagliflozin Versus Sitagliptin Therapy for Improvement of Myocardial Perfusion Reserve in Diabetic Patients With Coronary Artery disease_ELITE Trial
- ClinicalTrials.gov ID
- NCT03208465
- Acronym / sponsor ID
- ELITE / AMCCV2016-20
- Conditions
- Diabetes Mellitus, Coronary Disease
- Keywords
- Empagliflozin, Sitagliptin, Myocardial perfusion reserve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- CHEOL WHAN LEE, M.D., Ph.DUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Empagliflozin | Experimental | Drug: Empagliflozin |
| Patients with Sitagliptin | Active comparator | Drug: Sitagliptin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinIn empagliflozin group, patients will be prescribed empagliflozin 10mg/day. | Drug | Patients with Empagliflozin |
| SitagliptinIn sitagliptin group, patients will be prescribed sitagliptin 100mg/day. | Drug | Patients with Sitagliptin |
Primary outcome
Percent change in global myocardial perfusion reserve (MPR) index
Time frame: 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
3 secondary outcomes
Percent change in regional MPR index
Time frame: 6 months
Absolute change in regional MPR index
Time frame: 6 months
Absolute change in global MPR index
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Derived from this study: PubMed 34397987Oh 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.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin and Sitagliptin in people with Diabetes Mellitus and Coronary Disease, run by CHEOL WHAN LEE, M.D., Ph.D at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in global myocardial perfusion reserve (MPR) index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03208465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.