Overview

Effect of Adding Vildagliptin vs Glimepiride to Metformin on Inflammation's Markers in Type-2 Diabetic Patients With CAD

Status:
Completed
Trial end date:
2019-10-10
Target enrollment:
0
Participant gender:
All
Summary
The aim of this study is to evaluate the effect of adding Vildagliptin versus Glimepiride to Metformin on markers of inflammation, thrombosis, and atherosclerosis in diabetic patients with symptomatic Coronary artery diseases. The pre-specified established biological markers of inflammation, thrombosis, and atherosclerosis will include: Interleukin 1 beta (IL-1 beta)), hs-CRP, Atherogenic index and coronary risk index, Lipid profile. and adiponectin levels..
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Damanhour University
Collaborator:
Tanta University
Treatments:
Glimepiride
Metformin
Vildagliptin
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.