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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT04866667
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes
* HbA1c ≥7.0%
* Prior CVD cohort: age ≥50 and ≥1 of the following criteria.
* Prior MI
* Prior stroke or TIA
* Prior coronary, carotid or peripheral arterial revascularization
* N50% stenosis of coronary, carotid, or lower extremity arteries
* History of symptomatic CHD documented by Positive exercise stress test or any cardiac imaging or Unstable angina with ECG changes
* Asymptomatic cardiac ischemia Documented by positive nuclear imaging test, exercise test or dobutamine stress echo
* Chronic heart failure NYHA class II-III
* Chronic renal failure, eGFR \<60 mL/min per 1.73m2 MDRD eGFR \<60 mL/min per Cockcroft-Gault formula
* No Prior CVD group: Age ≥60 y and ≥1 of the following criteria.
* Microalbuminuria or proteinuria
* Hypertension and left ventricular hypertrophy by ECG or imaging
* Left ventricular systolic or diastolic dysfunction by imaging
* Ankle-brachial index b0.9
Exclusion Criteria:
* Type 1 diabetes
* other type diabetes
* Calcitonin ≥50 ng/L
* Use of a GLP-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any DPP-4 inhibitor within the 3 months prior to screening
* Use of insulin other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. Shortterm use of other insulin during this period in connection with intercurrent illness is allowed, at Investigators discretion
* Acute decompensation of glycemic control
* An acute coronary or cerebrovascular event in the previous 14 d
* Currently planned coronary, carotid, or peripheral artery revascularization
* Chronic heart failure (NYHA class IV)
* Current continuous renal replacement therapy
* End-stage liver disease
* History of solid organ transplant or awaiting solid organ transplant
* Malignant neoplasm
* Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
* Personal history of non-familial medullary thyroid carcinoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04866667
Study Brief:
Protocol Section:
NCT04866667