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| Name | Class |
|---|---|
| Tanta University | OTHER |
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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..
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vildagliptin / metformin | Experimental | Group I (n=40) are patients who are taking vildagliptin 50 mg oral tablet plus their metformin1000 mg oral tablet to control their blood sugar level. |
|
| glimepiride / metformin. | Experimental | Group II (n=40) are patients who are taking Glimepiride 4 mg oral tablet plus their metformin1000 mg oral tablet to control their blood sugar level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin 50 mg Oral Tablet | Drug | Patients who the endocrinologist prescribed them Vildagliptin 50 mg Oral Tablet plus their Metformin 1000 mg Oral Tablet to control their blood sugar level. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in markers of athero-thrombosis and inflammation ( interleukin (IL)-1 beta). | A-Change in interleukin (IL)-1 beta (IL-1ß) level will be determined by Enzyme-linked immunosorbent assay (ELISA). (unit: Picogram/milliliter pg/ml). | Baseline and 3 months |
| Change in High sensitivity C-reactive protein (hsCRP) level. | A- High sensitivity C-reactive protein (hsCRP) level will be determined by nephelometric procedure.(unit: mg/L) | Baseline and 3 months |
| Change in Adiponectin level. | A- Adiponectin level will be determined by Enzyme-linked immunosorbent assay (ELISA)..(unit: mg/L) | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lipid profile | 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)) | Baseline and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gamal Omran, PhD | Faculty of Pharmacy - Damanhour University. | Study Director |
| Tarek Mostafa, PhD | Tanta University | Study Director |
| Ahmed skokry, PhD | Alex.Armed Forces Hospital. | Study Director |
| Rehab Werida, PhD | Faculty of Pharmacy - Damanhour University. | Study Director |
| Mahmoud kabel | Faculty of Pharmacy - Damanhour University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmacy - Damanhour University. | Damanhūr | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22672501 | Background | Klempfner R, Leor J, Tenenbaum A, Fisman EZ, Goldenberg I. Effects of a vildagliptin/metformin combination on markers of atherosclerosis, thrombosis, and inflammation in diabetic patients with coronary artery disease. Cardiovasc Diabetol. 2012 Jun 6;11:60. doi: 10.1186/1475-2840-11-60. | |
| 9727886 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 1, 2018 | Oct 2, 2018 |
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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.
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| Metformin 1000 mg Oral Tablet | Drug | 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. |
|
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| Glimepiride upto 4 mg Oral Tablet | Drug | Patients who the endocrinologist prescribed them Glimepiride 4 mg oral tablet plus their Metformin 1000 mg Oral Tablet |
|
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| 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 . | Percent Change in (Low-density lipoprotein (LDL) cholesterol/High-density lipoprotein (HDL) cholesterol) =(combination treatment value - baseline value) / baseline value*100 | Baseline and 3 months |
| Change in Hemoglobin A1c (HbA1c). | A-Change in Hemoglobin A1c (HbA1c) by ion exchange method.(Unit : percent ) | Baseline and 3 months |
| Percent Change in (total cholesterol / High-density lipoprotein (HDL) cholesterol) for each patient before and after 3 months combination treatment for each group . | Percent Change in (total cholesterol / High-density lipoprotein (HDL) cholesterol) =(combination treatment value - baseline value) / baseline value*100 | Baseline and 3 months |
| King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998 Sep;21(9):1414-31. doi: 10.2337/diacare.21.9.1414. |
| 21955567 | Background | Yin M, Sillje HH, Meissner M, van Gilst WH, de Boer RA. Early and late effects of the DPP-4 inhibitor vildagliptin in a rat model of post-myocardial infarction heart failure. Cardiovasc Diabetol. 2011 Sep 28;10:85. doi: 10.1186/1475-2840-10-85. |
| 28532406 | Background | Younis A, Eskenazi D, Goldkorn R, Leor J, Naftali-Shani N, Fisman EZ, Tenenbaum A, Goldenberg I, Klempfner R. The addition of vildagliptin to metformin prevents the elevation of interleukin 1ss in patients with type 2 diabetes and coronary artery disease: a prospective, randomized, open-label study. Cardiovasc Diabetol. 2017 May 22;16(1):69. doi: 10.1186/s12933-017-0551-5. |
| 20560108 | Background | Derosa G, Maffioli P, Ferrari I, Mereu R, Ragonesi PD, Querci F, Franzetti IG, Gadaleta G, Ciccarelli L, Piccinni MN, D'Angelo A, Salvadeo SA. Effects of one year treatment of vildagliptin added to pioglitazone or glimepiride in poorly controlled type 2 diabetic patients. Horm Metab Res. 2010 Aug;42(9):663-9. doi: 10.1055/s-0030-1255036. Epub 2010 Jun 17. |
| 29497341 | Background | Kazemi T, Hajihosseini M, Moossavi M, Hemmati M, Ziaee M. Cardiovascular Risk Factors and Atherogenic Indices in an Iranian Population: Birjand East of Iran. Clin Med Insights Cardiol. 2018 Feb 20;12:1179546818759286. doi: 10.1177/1179546818759286. eCollection 2018. |
| 22019747 | Background | El-Mesallamy HO, Hamdy NM, Salman TM, Mahmoud S. Adiponectin and E-selectin concentrations in relation to inflammation in obese type 2 diabetic patients with coronary heart disease(s). Minerva Endocrinol. 2011 Sep;36(3):163-70. |
| 33002553 | Result | Werida R, Kabel M, Omran G, Shokry A, Mostafa T. Comparative clinical study evaluating the effect of adding Vildagliptin versus Glimepiride to ongoing Metformin therapy on diabetic patients with symptomatic coronary artery disease. Diabetes Res Clin Pract. 2020 Dec;170:108473. doi: 10.1016/j.diabres.2020.108473. Epub 2020 Sep 28. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| D013607 | Tablets |
| D008687 | Metformin |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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