Effect of Vildagliptin Versus Dapagliflozin as Add on Therapy to Metformin on Cardiovascular Risk Factors

NCT07077525 | Completed Phase 4

• 1 other identifier: IDE00302
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching hypothesis of this study is that vildagliptin (vilda) as add on therapy to metformin (met) in Egyptian type 2 diabetic obese patient will produce an equal, if not better, glycemic control and will reduce cardiovascular risk factors compared to dapagliflozin (dapa). However, there are interindividual differences in response to vildagliptin among Egyptian population which might be due to gender difference and/ or mutation in one or more of the DDP-4 gene, GLP1 receptor gene and KATP channel gene. These potential differences could favor pharmacogenomic selection of candidate patient. Global aim of this study: To compare effects of the DPP-4 inhibitor (vildagliptin) versus SGLT4 inhibiter (dapagliflozin) as add on therapy to metformin to control cardiovascular risk factors in Egyptian obese patients with type 2 diabetes and furthermore to investigate the possible interindividual variation to vildagliptins response. Specific aims: Evaluation of efficacy and safety of vildagliptin plus metformin versus dapagliflozin plus metformin in Egyptian obese patients with type 2 diabetes mellitus (T2DM). Examining of interindividual difference in hypoglycemic response to the used treatment arms among participants of the study. Assessment of response in relation to sex difference in Egyptian population. Investigation of vasculoprotective effects of different treatment with special emphasis on atherogenesis. Investigating the efficacy of different treatment in controlling individual cardiovascular risk factors in preventing or slowing atherosclerotic cardiovascular diseases in people with diabetes Exploring of whether genetic variation in the DPP4 gene, GLP1 receptor and KATP channel affects incretin levels, insulin secretion, and glucose tolerance in participants of the study. Examining the associations between genetic variations of DPP-4 gene in men and women involved in this study

Conditions

Type 2 Diabetes

Keywords

Diabetes mellitus; Vildagliptin; Dapagliflozin; Metformin; Cardiovascular risk factors

Outcome Measures

Primary Outcomes (3)

• Evaluation of HbA1c level

  Measurement of serum levels of HbA1C as a percentage (%) at 0 (baseline) 6 and 12 months. Change of serum level of HbA1C due to treatments after 12 months and determine the frequency of participants achieved reduction of HbA1c level by more than 1%

  0,6 and 12 months of treatment

• Evaluation of serum level of FBG

  Measurement of serum level of FBG as (mg/dl) at 0,6 and 12 months. Change of serum level of FBG due to treatments after 12 months

  0, 6 and 12 months

• Evaluation of serum level of PPG

  Measurement of serum level of PPG as (mg/dl) at 0,6 and 12 months. Change of serum level of PPG due to treatments after 12 months

  0.6 and 12 months

Secondary Outcomes (7)

• Evaluation of Body mass index (BMI)

  0,6 and 12 months of treatment

• Evaluation of serum inflammatory cytokines

  0 and 12 months of treatment

• Assessment of genetic variation

  After 12 months of treatment

• Assessment of lipid profile parameters

  0, 6 and 12 months of treatment

• Assessment of a common variant, SNP rs6741949, in the DPP4 gene

  After 12 months of treatment

Other Outcomes (7)

• Measurement of homocysteine and vitamin B12 serum levels

  0 and 12 months

• Measurement of stromal cell derived factor and vascular cell adhesion molecule 1 in serum

  0 and 12 months of treatment

• Evaluation of serum liver biomarkers

  0, 6 and 12 months of treatment

Study Arms (2)

Dapagliflozin plus metformin

ACTIVE COMPARATOR

70 patients with T2DM: will be given metformin plus vildagliptin combination as per the standard of care in a physician's practice.

Combination Product: Dapagliflozin + Metformin

Vildagliptin plus metformin

ACTIVE COMPARATOR

150 patients with T2DM: will be treated with metformin plus dapagliflozin combination as per the standard of care in a physician's practice.

Combination Product: Vildagliptin + Metformin

Interventions

Dapagliflozin + Metformin COMBINATION_PRODUCT

70 patients with T2DM were treated once daily with Dapa plus Met combination (Dapavildactin plus®, Liptis Pharmaceuticals, Egypt) in a dose titrated from 5 mg Dapa and 1000 mg Met up to a maximum of 10 mg Dapa and 2000 mg metformin as per the standard of care in a physician's practice

Dapagliflozin plus metformin

Vildagliptin + Metformin COMBINATION_PRODUCT

126 patients with T2DM were treated with Vilda plus Met combination (Gliptus plus®, EVA pharma, Egypt ) in initial daily dose of 50 mg Vilda and 500 mg Met . The medication is titrated gradually up to Vilda 50 mg and metformin 1000 mg twice daily as per the standard of care in a physician's practice

Vildagliptin plus metformin

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• HbA1c level between 6.5% - 10.0% (47.5-107.7 mmol/mol) before study initiation
• obese (BMI ≥30 kg/m2)
• no history of established CV disease
• ability to understand and to sign a written informed consent document
• outpatients
• TSH and liver function within normal limit and no evidence of kidney diseases.

You may not qualify if:

• Diagnosis of T1DM
• subjects with any serious medical condition requiring hospitalization
• subjects with unstable cardiac disorders such as heart failure, refractory angina, uncontrolled arrhythmias, critical valvular heart disease and severe uncontrolled hypertension
• renal or liver failure
• females of childbearing potential or who are pregnant
• breast-feeding
• subjects using any drug that could interfere with the glucose level (e.g. systemic corticosteroids) and participation in any other clinical trial.

Sponsors & Collaborators

• Al-Azhar University: lead
• General Committee of Teaching Hospitals and Institutes, Egypt: collaborator

Study Sites (1)

Al-Azhar university

Cairo, Cairo Governorate, 11768, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

dapagliflozin; Metformin; Vildagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Nitriles; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Khalid S Hassanien, Assistant lecturer

  al-azhar university, faculty of pharmacy, cairo.

  PRINCIPAL INVESTIGATOR

• Memy M Hegazy, professor

  al-azhar university, faculty of pharmacy, cairo.

  STUDY DIRECTOR

• Atef A Bassyouni, Profepssor

  Medical consultant . National Institute of Diabetes and Endocrinology

  STUDY CHAIR

• Raed S Ismail, Professor

  al-azhar university, faculty of pharmacy, cairo.

  STUDY CHAIR

• Mohammed F Elshafie, Assistant professor

  al-azhar university, faculty of pharmacy, cairo.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer, Faculty of Pharmacy, Al-Azhar University

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 22, 2025
• Study Start: June 1, 2023
• Primary Completion: August 10, 2024
• Study Completion: August 31, 2024
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)