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

NCT ID: NCT03693560

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-08
• Study Completion Date: 2019-10-10

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.

Conditions

Coronary Artery Disease; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Vildagliptin 50 mg Oral Tablet

Intervention Type: 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.

Metformin 1000 mg Oral Tablet

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Metformin 1000 mg Oral Tablet

Intervention Type: 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.

Glimepiride upto 4 mg Oral Tablet

Intervention Type: DRUG

Patients who the endocrinologist prescribed them Glimepiride 4 mg oral tablet plus their Metformin 1000 mg Oral Tablet

Interventions

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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Galvus 50 mg; Glucophage 1000 mg; Amaryl 4 mg

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: collaborator

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Werida

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gamal Omran, PhD

Role: STUDY_DIRECTOR

Faculty of Pharmacy - Damanhour University.

Tarek Mostafa, PhD

Role: STUDY_DIRECTOR

Tanta University

Ahmed skokry, PhD

Role: STUDY_DIRECTOR

Alex.Armed Forces Hospital.

Rehab Werida, PhD

Role: STUDY_DIRECTOR

Faculty of Pharmacy - Damanhour University.

Mahmoud kabel

Role: PRINCIPAL_INVESTIGATOR

Faculty of Pharmacy - Damanhour University

Locations

Faculty of Pharmacy - Damanhour University.

Damanhūr, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 22672501 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9727886 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21955567 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28532406 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20560108 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29497341 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22019747 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33002553 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

vildaglipitin in CAD

Identifier Type: -

Identifier Source: org_study_id