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

June 10, 2023 updated by: Rehab Werida, Damanhour University

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 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..

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Damanhūr, Egypt
        • Faculty of Pharmacy - Damanhour University.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Galvus 50 mg
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.
Other Names:
  • Glucophage 1000 mg
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.
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.
Other Names:
  • Glucophage 1000 mg
Drug: Glimepiride upto 4 mg Oral Tablet
Patients who the endocrinologist prescribed them Glimepiride 4 mg oral tablet plus their Metformin 1000 mg Oral Tablet
Other Names:
  • Amaryl 4 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and 3 months
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)
Baseline and 3 months
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)
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
Baseline and 3 months
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
Baseline and 3 months
Change in Hemoglobin A1c (HbA1c).
Time Frame: Baseline and 3 months
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 .
Time Frame: Baseline and 3 months
Percent Change in (total cholesterol / High-density lipoprotein (HDL) cholesterol) =(combination treatment value - baseline value) / baseline value*100
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Collaborators

Tanta University

Investigators

  • 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.
  • Principal Investigator: Mahmoud kabel, Faculty of Pharmacy - Damanhour University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2018

Primary Completion (Actual)

September 10, 2019

Study Completion (Actual)

October 10, 2019

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

October 2, 2018

First Posted (Actual)

October 3, 2018

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 10, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • vildaglipitin in CAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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