Empagliflozin Versus Vildagliptin in CAD Patients With T2DM

Status Recruiting

Clinical Trial Summary

We compared the cardioprotective effects of empagliflozin, an SGLT2 inhibitor, with those of vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, focusing on various inflammatory biomarkers lipid profile, and cardiac function, in patients with type 2 diabetes mellitus (T2DM).

Clinical Trial Description

This was a prospective, randomized, double-dummy, parallel-group trial that enrolled 120 patients with T2DM. The patients were randomized 1: 1 for 12-week administration of empagliflozin or vildagliptin. by using consecutive ascending randomization numbers in the treatment blocks allocated to each study site. The randomization was stratified by the presence or absence of statin and oral antidiabetic therapy. The randomization list was produced using an automated random number generator. Clinical parameters, assessment of atrial myocardial function, LVEF%, LA diameter, glycemic and lipid profile, adiponectin, high-sensitivity C-reactive protein, and Sortilin levels will be determined at baseline and after the 6 months of treatment period. Patient compliance was evaluated by the counting of pills by a physician at selected time-points. In addition, patients were provided with individual diary cards to record administration of the study medication on a daily basis. These cards were checked regularly by site staff. The study will be approved by the local ethics committee and was conducted in accordance with the Declaration of Helsinki and its amendments. All included patients provided written informed consent. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06313008
Study type	Interventional
Source	Damanhour University
Contact	Rehab H Werida, Ass. Prof.
Phone	01005359968
Email	rehabwrieda@pharm.dmu.edu.eg
Status	Recruiting
Phase	N/A
Start date	August 10, 2023
Completion date	June 10, 2024

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