Empagliflozin Versus Vildagliptin in CAD Patients With T2DM

Damanhour University

Status: Completed

Conditions: Coronary Artery Disease; Type 2 Diabetes

Treatments: Drug: Vildagliptin 50 MG; Drug: Empagliflozin 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06313008

EMBA-VILDA-Response trial.

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. T2DM patients with chronic stable angina.
2. patients with glycated hemoglobin (HbA1c) levels of 6.0-10.0%.
3. patients aged 20-80 years.
4. patients with a body mass index of ≥ 22 kg/m2.
5. patients who provided written informed consent.

Exclusion criteria

1. patients with type 1 diabetes mellitus or secondary diabetes mellitus.
2. patients with renal dysfunction (estimated glomerular filtration rate < 45 mL/min/1.73 m2).
3. patients with left ventricular ejection fraction (LVEF) < 30%.
4. patients with untreated cancer.
5. patients with hepatic cirrhosis.
6. patients with liver failure that was virus-, autoimmune- or drug-induced.
7. patients with alcoholism.
8. pregnant or breastfeeding patients, or those planning to become pregnant during the course of the study.
9. patients allergic to empagliflozin or vildagliptin.
10. patients with anemia (hemoglobin < 12 g/dL).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Empagliflozin

Experimental group

Description:

Eligible subjects were randomly and equally assigned to the empagliflozin add-on group (empagliflozin 10 mg/ day).

Treatment:

Drug: Empagliflozin 10 MG

Vildagliptin

Experimental group

Description:

60 patients recieved vildagliptin as add-on group (vildagliptin 50 mg/day as the initial dose).

Treatment:

Drug: Vildagliptin 50 MG