Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07417618
Eligibility Criteria:
The database analyses will be new-user active-comparative studies, conducted using 3 national United States claims databases, where we compare the effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on preventing atherosclerotic cardiovascular events.
Optum: Eligible cohort entry period from September 18, 2014 to August 31, 2025. Marketscan: Eligible cohort entry from October 1, 2016 to October 31, 2023. Medicare: Eligible cohort entry from September 18, 2014 to October 31, 2020.
POPULATION WITH ASCVD
Inclusion Criteria:
* History of ASCVD (defined as MI, ACS, stable/unstable angina surgical or percutaneous coronary/other arterial revascularization procedure, ischemic stroke, TIA, aortic aneurysm, peripheral artery disease)
* BMI \>= 25.0kg/m2
* Type 2 Diabetes
Exclusion Criteria:
* Medullary thyroid carcinoma
* MEN syndrome type 2
* Malignancy
* Type 1 diabetes or secondary diabetes
* End-stage renal disease or dialysis
* Uncontrolled diabetic retinopathy or maculopathy
* Pregnancy
* Bariatric surgery
* Prior use of pramlintide, or any GLP-1RA except injectable semaglutide/tirzepatide/dulaglutide, or any DPP4i except sitagliptin
* CV-event or intervention
* Concurrent use of both study drugs
POPULATION WITHOUT ASCVD
Inclusion Criteria:
* BMI \>=25.0kg/m2
* Type 2 diabetes
Exclusion Criteria:
* History of ASCVD (defined as MI, ACS, stable/unstable angina surgical or percutaneous coronary/other arterial revascularization procedure, ischemic stroke, TIA, aortic aneurysm, peripheral artery disease)
* Medullary thyroid carcinoma
* MEN syndrome type 2
* Malignancy
* Type 1 diabetes or secondary diabetes
* End-stage renal disease or dialysis
* Uncontrolled diabetic retinopathy or maculopathy
* Pregnancy
* Bariatric surgery
* Prior use of pramlintide, or any GLP-1RA except injectable semaglutide/tirzepatide/dulaglutide, or any DPP4i except sitagliptin
* Concurrent use of both study drugs
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07417618
Study Brief:
Protocol Section:
NCT07417618