Coronary Artery Disease, Diabetes Mellitus, Type 2
Conditions
Brief 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..
Detailed description
The study is designed as a single-center, randomized, double-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.
Interventions
Patients who the endocrinologist prescribed them Vildagliptin 50 mg Oral Tablet plus their Metformin 1000 mg Oral Tablet to control their blood sugar level.
Patients with Coronary artery diseases.and uncontrolled Diabetes Mellitus type 2 who's taking Metformin 1000 mg Oral Tablet only will be enrolled from endocrinology clinic.
DRUGGlimepiride upto 4 mg Oral Tablet
Patients who the endocrinologist prescribed them Glimepiride 4 mg oral tablet plus their Metformin 1000 mg Oral Tablet
Sponsors
Tanta University
Damanhour University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in markers of athero-thrombosis and inflammation ( interleukin (IL)-1 beta). | Baseline and 3 months | A-Change in interleukin (IL)-1 beta (IL-1ß) level will be determined by Enzyme-linked immunosorbent assay (ELISA). (unit: Picogram/milliliter pg/ml). |
| Change in High sensitivity C-reactive protein (hsCRP) level. | Baseline and 3 months | A- High sensitivity C-reactive protein (hsCRP) level will be determined by nephelometric procedure.(unit: mg/L) |
| Change in Adiponectin level. | Baseline and 3 months | A- Adiponectin level will be determined by Enzyme-linked immunosorbent assay (ELISA)..(unit: mg/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lipid profile | Baseline and 3 months | A-Change inTriglycerides (TGs). (Unit : milligrams per deciliter (mg/dL)) B-Change in total cholesterol (TCH). (Unit : milligrams per deciliter (mg/dL)) C-Change in high-density lipoprotein (HDL-C). (Unit : milligrams per deciliter (mg/dL)) D-change in Low density lipoprotein cholesterol (LDL-C). (Unit : milligrams per deciliter (mg/dL)) |
| Percent Change in (total cholesterol / High-density lipoprotein (HDL) cholesterol) for each patient before and after 3 months combination treatment for each group . | Baseline and 3 months | Percent Change in (total cholesterol / High-density lipoprotein (HDL) cholesterol) =(combination treatment value - baseline value) / baseline value\*100 |
| Percent Change in ( Low-density lipoprotein (LDL) cholesterol / High-density lipoprotein (HDL) cholesterol ) for each patient before and after 3 months combination treatment for each group . | Baseline and 3 months | Percent Change in (Low-density lipoprotein (LDL) cholesterol/High-density lipoprotein (HDL) cholesterol) =(combination treatment value - baseline value) / baseline value\*100 |
| Change in Hemoglobin A1c (HbA1c). | Baseline and 3 months | A-Change in Hemoglobin A1c (HbA1c) by ion exchange method.(Unit : percent ) |
Countries
Egypt
Outcome results
None listed