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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT03693560
Eligibility Criteria:
Inclusion Criteria:
* Adult patients with Type II-diabetes mellitus on metformin who are planned to be managed with vildagliptin or glimepiride plus metformin at the time of inclusion.
* Symptomatic Coronary Artery Diseases. (\>30 days).
Exclusion Criteria:
* Hepatic impairment.
* Active malignancy.
* Planned surgical intervention.
* Any signs of hypersensitivity or contraindication to study drugs developed.
* Any patient with any signs of active infection or thrombosis at the time of assessment.
* Addition of any antidiabetic medications or insulin during follows up.
* Chronic inflammatory disease (i.e. inflammatory bowel disease, lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection).
* Clinically advanced congestive heart failure - New York Heart Association III-IV
* Severe left ventricular dysfunction (LVEF\<30%) with New York Heart Association II or any New York Heart Association class with documented recent heart failure decompensation (\<3 months)
* Severe stable cardiac angina Community Competence Scale III - IV or Unstable angina
* Pregnancy, lactation or child-bearing potential.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Study:
NCT03693560
Study Brief:
Protocol Section:
NCT03693560