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

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

Interventions

COMBINATION_PRODUCT

Dapagliflozin + Metformin

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

COMBINATION_PRODUCT

Vildagliptin + Metformin

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

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt

  collaborator OTHER_GOV

• Al-Azhar University

  lead OTHER

Principal Investigators

• Khalid S Hassanien, Assistant lecturer · al-azhar university, faculty of pharmacy, cairo.

• Memy M Hegazy, professor · al-azhar university, faculty of pharmacy, cairo.

• Atef A Bassyouni, Profepssor · Medical consultant . National Institute of Diabetes and Endocrinology

• Raed S Ismail, Professor · al-azhar university, faculty of pharmacy, cairo.

• Mohammed F Elshafie, Assistant professor · al-azhar university, faculty of pharmacy, cairo.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-01

Primary Completion

2024-08-10

Completion

2024-08-31

Countries

• Egypt

Study Locations