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Empagliflozin Versus Vildagliptin in CAD Patients With T2DM

D

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

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

Trial contacts and locations

1

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Central trial contact

Naglaa Khedr, Prof.; Rehab H Werida, Ass. Prof.

Data sourced from clinicaltrials.gov

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