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:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT06659718
Eligibility Criteria:
Eligible cohort entry dates:
Market availability of oral semaglutide in the US began on 19th September 2019.
Optum: Study period between 20th Sept 2019 - 29th February 2024 Marketscan: Study period between 20th Sept 2019 - 31st Dec 2022 Medicare: Study period between 20th Sept 2019 - 31st Dec 2020
Inclusion Criteria:
* Type 2 diabetes mellitus
* Male or female, age equal to or above 50 years
At least one of the following conditions:
* Coronary heart disease defined by at least one of the following criteria:
i. Prior myocardial infarction ii. Prior coronary revascularization procedure ii. 50% or above stenosis in coronary artery documented by cardiac catheterization, computerized tomography coronary angiography iv. Coronary heart disease with ischemia documented by stress test with any imaging modality
* Cerebrovascular disease defined by at least one of the following criteria:
i. Prior stroke ii. Prior carotid artery revascularization procedure iii. 50% or above stenosis in carotid artery documented by x-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound
* Symptomatic peripheral artery disease (PAD) defined by at least one of the following criteria:
i. Intermittent claudication with an Ankle-brachial index (ABI) below 0.85 at rest ii. Intermittent claudication with a 50% or above stenosis in peripheral artery (excluding carotid) documented by x-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound iii. Prior peripheral artery(excluding carotid) revascularization procedure iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding trauma or osteomyelitis)
* Chronic kidney disease defined as: i. eGFR below 60mL/min/1.73 m\^2 (based on medical records using latest available and no more than 6 months old assessment)
Exclusion Criteria:
* Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischemic attack within the past 60 days prior to the day of screening
* Heart failure presently classified as being in New York Heart Association Class IV
* Treatment with any glucagon-like peptide-1 receptor agonist within 30 days before screening
* Semaglutide
* History of MEN-2 or family history of medullary thyroid cancer
* History of pancreatitis
* History of or planning bariatric surgery, including banding procedures or surgical gastric and/or intestinal bypass
* Plans for pregnancy during the course of the study for women of child-bearing potential
* History of cancer, other than non-melanoma skin cancer, that required therapy in the 5 years prior to randomization
* Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR \<30 ml/min/1.73 m2)
* Proliferative retinopathy or maculopathy requiring acute treatment
* History of diabetic ketoacidosis
* Missing age or gender
* Nursing home admission
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06659718
Study Brief:
Protocol Section:
NCT06659718