EXpanded Combination of Evolocumab Plus Empagliflozin on Diabetes: EXCEED-BHS3 Trial (NCT03932721) | Clinical Trial Compass
CompletedPhase 4
EXpanded Combination of Evolocumab Plus Empagliflozin on Diabetes: EXCEED-BHS3 Trial
Brazil110 participantsStarted 2018-10-01
Plain-language summary
Based on the current evidence, empagliflozin could reduce cardiovascular morbidity and mortality in Diabetes Mellitus Type 2 (T2DM). Anti-PCSK9 therapy (evolocumab) can reduce the major cardiovascular events incidence in secondary prevention individuals, some of them presenting T2DM. The beneficial effect of the combined use of these two agents in T2DM remains unknown. Evaluating the effect of evolocumab on top of the best of care therapy for T2DM, including empaglifozin, on endothelial function may indicate the existence of some benefit related to cardiovascular outcomes.
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* T2DM between 40 and 70 years old;
* Adequate glycemic control (HbA1c 7 to 9%) after run-in phase;
* Adequate blood pressure control (SBP ≤ 140 mm Hg)
* Maximal tolerated dose of statins and LDL-C between 70 and 100 mg/dL.
Exclusion Criteria:
* HbA1c \> 9% after run-in phase;
* Hospitalization for unstable angina or acute myocardial infarction within 6 months prior to enrolment;
* Acute stroke or transient ischemic attack (TIA) within 6 months prior to enrolment;
* Less than two months post coronary artery revascularization;
* BP ≥ 140 x 90 after anti-hypertensive medication adjustment;
* FMD \<2% or \> 10% at the time of randomization;
* Triglycerides \> 500 mg/dL;
* Known allergy to any of the study drugs;
* Severe coronary artery disease or heart failure;
* Systemic inflammation (C-reactive protein ≥ 5 mg/dL);
* Pregnancy or women during reproductive age;
* Active smoking or stopped smoking less than six months ago;
* Participation in other clinical studies or whose participation ended less than six months -ago.
* Use of SGLT2i or GLP-1a in the last sex months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in the percentage change in flow mediated dilation (FMD)