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

NCT03693560 | Completed Phase 4 DMC

• 1 other identifier: vildaglipitin in CAD
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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..

Conditions

Coronary Artery Disease; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Change in Lipid profile

  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 .

  Baseline and 3 months

• Change in Hemoglobin A1c (HbA1c).

  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 .

  Baseline and 3 months

Study Arms (2)

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.

Drug: Vildagliptin 50 mg Oral Tablet; Drug: Metformin 1000 mg Oral Tablet

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.

Drug: Metformin 1000 mg Oral Tablet; Drug: Glimepiride upto 4 mg Oral Tablet

Interventions

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.

Also known as: Galvus 50 mg

vildagliptin / metformin

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.

Also known as: Glucophage 1000 mg

glimepiride / metformin.; vildagliptin / metformin

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

Also known as: Amaryl 4 mg

glimepiride / metformin.

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic Coronary Artery Diseases. (\>30 days).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead
• Tanta University: collaborator

Study Sites (1)

Faculty of Pharmacy - Damanhour University.

Damanhūr, Egypt

Location

Related Publications (8)

• 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.

  PMID: 22672501 BACKGROUND

• 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.

  PMID: 9727886 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.

  PMID: 21955567 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.

  PMID: 28532406 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.

  PMID: 20560108 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.

  PMID: 29497341 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.

  PMID: 22019747 BACKGROUND

• 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.

  PMID: 33002553 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus, Type 2

Interventions

Vildagliptin; Tablets; Metformin; glimepiride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Biguanides; Guanidines; Amidines

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 3, 2018
• Study Start: October 8, 2018
• Primary Completion: September 10, 2019
• Study Completion: October 10, 2019
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)