Empagliflozin Versus Vildagliptin in CAD Patients With T2DM

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Coronary Artery Disease
• Interventions: Drug: Empagliflozin 10 MG; Drug: Vildagliptin 50 MG

• Registration Number: NCT06313008
• Lead Sponsor: Damanhour University

Brief 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.

Study Timeline

• Study Start: 2023-08-10
• Study First Submitted: 2024-03-09
• Study First Submitted QC: 2024-03-09
• Study First Posted: 2024-03-15
• Primary Completion: 2024-09-30
• Study Completion: 2024-10-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin	Empagliflozin 10 MG	Eligible subjects were randomly and equally assigned to the empagliflozin add-on group (empagliflozin 10 mg/ day).
Vildagliptin	Vildagliptin 50 MG	60 patients recieved vildagliptin as add-on group (vildagliptin 50 mg/day as the initial dose).

Primary Outcome Measures

Name	Time	Method
Sortilin (ng/ml)	6 months	Serum Biomarkers
LVEF %	6 months	echocardiographic measurements
LDL (mg/dl)	6 months	Lipid profile

Secondary Outcome Measures

Name	Time	Method
FBG (mg/dl)	6 Months	Serum level
HbA1c %	6 months	Glycemic control
hsCRP (mg/L)	6 months	Serum Biomarkers

Trial Locations

Locations (1)

Rehab Hussein Werida; 🇪🇬 Damanhūr, Elbehairah, Egypt