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

Timeline

Start

2023-06-01

Primary completion

2024-08-10

Completion

2024-08-31

Drugs

Indications