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Clinical Trial 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..

Clinical Trial Description

The study is designed as a single-center, randomized, non-blinded, clinical trial to provide evidence on the effects of vildagliptin on key biomarkers of atherothrombosis and inflammation. The investigators plan to prospectively enroll 80 patients with proven coronary artery disease ,Diabetes type2 and randomize them in a 1:1 ratio to either vildagliptin-metformin therapy (n=40) or glimepiride /metformin therapy (n=40).

1. All participants agreed to take part in this clinical study and provide informed consent.

2. Patients with Coronary artery diseases.and uncontrolled Diabetes type2 who's taking metformin only will be enrolled (n=80) from endocrinology clinic at Alexandria Armed Forces hospital.

3. Complete physical, laboratory, radiological assessment will be done for all patients to exclude any signs of inflammation or thrombosis.

4. Serum samples will be collected for measuring the biomarkers.

5. All enrolled patients will be mentioned as two groups; Group I (n=40) are patients who the endocrinologist prescribed them vildagliptin plus their metformin to control their blood sugar level. Group II (n=40) are patients who the endocrinologist prescribed them glimepiride plus their metformin.

6. All patients will be followed up during 3 months' period.

7. At the end of 3 months on the new regimen, steps 4 and 5 will be repeated.

8. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.

9. Measuring outcome: The primary outcome is the change of serum levels of the measured inflammatory markers after 3 months.

10. Results, conclusion, discussion and recommendations will be given. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03693560
Study type Interventional
Source Damanhour University
Status Active, not recruiting
Phase Phase 4
Start date October 8, 2018
Completion date July 1, 2019

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