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 States13,299 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 range40 Years
SexALL
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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…
What they're measuring
1
Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3)
Timeframe: Randomization up to Study Completion (Approximate Maximum 54 Months)