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

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Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 25, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

February 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in markers of athero-thrombosis and inflammation ( interleukin (IL)-1 beta).[ Time Frame: 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.[ Time Frame: 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.[ Time Frame: Baseline and 3 months ]

A- Adiponectin level will be determined by Enzyme-linked immunosorbent assay (ELISA)..(unit: mg/L)

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Change in Lipid profile[ Time Frame: 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 ( Low-density lipoprotein (LDL) cholesterol / High-density lipoprotein (HDL) cholesterol ) for each patient before and after 3 months combination treatment for each group .[ Time Frame: 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).[ Time Frame: Baseline and 3 months ]
A-Change in Hemoglobin A1c (HbA1c) by ion exchange method.(Unit : percent )
Percent Change in (total cholesterol / High-density lipoprotein (HDL) cholesterol) for each patient before and after 3 months combination treatment for each group .[ Time Frame: Baseline and 3 months ]
Percent Change in (total cholesterol / High-density lipoprotein (HDL) cholesterol) =(combination treatment value - baseline value) / baseline value*100

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Effect of Adding Vildagliptin Versus Glimepiride to Metformin on Markers of Inflammation, Thrombosis, and Atherosclerosis in Diabetic Patients With Symptomatic Coronary Artery Diseases

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, 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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Vildagliptin 50 mg Oral Tablet
Patients who the endocrinologist prescribed them Vildagliptin 50 mg Oral Tablet plus their Metformin 1000 mg Oral Tablet to control their blood sugar level.
Drug: Metformin 1000 mg Oral Tablet
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.
Drug: Glimepiride 4 mg Oral Tablet
Patients who the endocrinologist prescribed them Glimepiride 4 mg oral tablet plus their Metformin 1000 mg Oral Tablet

Study Arms

Experimental: vildagliptin / metformin
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.
Experimental: glimepiride / metformin.
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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

February 2019

Estimated Primary Completion Date

February 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

25 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Egypt

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Damanhour University

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Gamal Omran, PhD Faculty of Pharmacy - Damanhour University.
Study Director: Tarek Mostafa, PhD Faculty of Pharmacy- Tanta University.
Study Director: Ahmed skokry, PhD Alex.Armed Forces Hospital.
Study Director: Rehab Werida, PhD Faculty of Pharmacy - Damanhour University.

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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