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:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT05948969
Eligibility Criteria:
Inclusion Criteria:
* T2D diagnosis in the medical record
* ASCVD, defined as follows:
1. Known Coronary artery disease (CAD), prior Acute coronary syndrome (ACS), or coronary artery revascularization
2. Prior TIA/ischemic stroke or known carotid or intracerebral atherosclerosis, or prior carotid revascularization
3. Prior Peripheral artery disease (PAD) including symptomatic claudication or pe-ripheral revascularization
Exclusion Criteria:
* Current participation in an interventional clinical assessment of an investigational drug/device (excluding assessments related to COVID-19)
* Currently receiving any SGLT2i or GLP-1RA
* Known allergy/hypersensitivity/intolerance/contraindication to SGLT2i or GLP-1RA
* Currently receiving comfort care or enrolled in hospice
* Life expectancy \<1 year
* History of or plan for heart transplantation or ventricular assist device
* Current or planned hemodialysis
* Decompensated end stage liver disease
* History of Fournier's Gangrene
* Type 1 diabetes
* Prior history of diabetic ketoacidosis
* Pregnancy or active breastfeeding
* History of Pancreatitis or pancreatic cancer
* History of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05948969
Study Brief:
Protocol Section:
NCT05948969