NCT06313008

Empagliflozin Versus Vildagliptin in CAD Patients With T2DM

A Clinical Study Comparing Effects of Empagliflozin Versus Vildagliptin on Inflammatory Biomarkers, and Atrial Function in Coronary Artery Disease Patients With Type 2 Diabetes: EMBA-VILDA-Response Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This was a prospective, randomized, double-dummy, parallel-group trial that enrolled 120 patients with T2DM. The patients were randomized 1: 1 for 6 months 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.

Conditions

• Coronary Artery Disease
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Empagliflozin 10 MG	eligible subjects were randomly and equally assigned to the empagliflozin add-on group (empagliflozin 10 mg/ day).
DRUG	Vildagliptin 50 MG	eligible subjects were randomly and equally assigned to vildagliptin add-on group (vildagliptin 50 mg/day as the initial dose).

Timeline

• Start date: 2023-08-10
• Primary completion: 2024-09-30
• Completion: 2024-10-10
• First posted: 2024-03-15
• Last updated: 2024-11-29

Locations

1 site across 1 country: Egypt