A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Pa… (NCT04255433) | Clinical Trial Compass
CompletedPhase 3
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
United States, Argentina, Australia13,299 participantsStarted 2020-05-29
Plain-language summary
The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.
Who can participate
Age range
40 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:
* Men or women at least 40 years old with a diagnosis of type 2 diabetes
* Established cardiovascular disease, including at least 1 of the following:
* Coronary artery disease (CAD) with any of the following:
* Documented history of spontaneous myocardial infarction (MI)
* ≥50% stenosis in 1 or more major coronary arteries, determined by invasive angiography
* ≥50% stenosis in 2 or more major coronary arteries, determined by computed tomography coronary angiography (CTCA)
* History of surgical or percutaneous coronary revascularization procedure
* Cerebrovascular disease - any of the following:
* Documented history of ischemic stroke
* Carotid arterial disease with ≥50% stenosis, documented by carotid ultrasound, magnetic resonance imaging (MRI), or angiography
* Carotid stenting or surgical revascularization
* Peripheral arterial disease with either of the following:
* Intermittent claudication and ankle-brachial index \<0.9
* Prior nontraumatic amputation or peripheral vascular procedure (eg, stenting or surgical revascularization), due to peripheral arterial ischemia
* Note: Supporting medical documentation is required in all instances
* HbA1c ≥7% (≥53 mmol/mol) and ≤10.5% (≤91.3 mmol/mol) based on central laboratory assessment at screening
* Body mass index (BMI) ≥25 kg/m2
* At the time of signing the informed consent: Contraceptive use by men or women should be consistent with local regulations regardin…
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
Number of Participants From Randomization to First Occurrence of Death From MACE-3 [Composite Endpoint of Major Adverse Cardiovascular Events Death From Cardiovascular Causes, Myocardial Infarction (MI) or Stroke]
Timeframe: From randomization (week 0) up to week 259