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 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT05182359
Eligibility Criteria:
Inclusion Criteria:
* Patients receiving care at a University Hospitals location
* Patients 40-89 year of age
* Diagnosis of Type 2 Diabetes Mellitus
* Eligible for but not currently prescribed a SGLT2i or GLP1RA per drug label. This includes a diagnosis of type 2 diabetes plus established atherosclerotic cardiovascular disease or high risk for atherosclerotic cardiovascular disease (including age ≥55 years with coronary, carotid, or lower-extremity atherosclerotic disease) or heart failure or chronic kidney disease with or without albuminuria.
* Patients that are able to provide consent
Exclusion Criteria:
* Intolerance or contraindication for use of both GLP1RA and SGLT2i
* Use of SGLT2i or GLP1RA within the 3 months prior to enrollment
* History of, an active, or untreated malignancy, in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years prior to, or are receiving or planning to receive therapy for cancer, at screening
* Patients that have Systemic Lupus Erythematous (SLE)
* End-stage renal disease
* Pregnancy (as determined by self-report)
* Inability to understand English (since must be able to understand risk report which is not translated by the manufacturer)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
89 Years
Study:
NCT05182359
Study Brief:
Protocol Section:
NCT05182359