Empagliflozin Versus Vildagliptin in CAD Patients With T2DM

April 13, 2024 updated by: Rehab Werida, Damanhour University

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.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Empagliflozin
Eligible subjects were randomly and equally assigned to the empagliflozin add-on group (empagliflozin 10 mg/ day).
Drug: Empagliflozin 10 MG
eligible subjects were randomly and equally assigned to the empagliflozin add-on group (empagliflozin 10 mg/ day).
Other Names:
  • Empa
Experimental: Vildagliptin
60 patients recieved vildagliptin as add-on group (vildagliptin 50 mg/day as the initial dose).
Drug: Vildagliptin 50 MG
eligible subjects were randomly and equally assigned to vildagliptin add-on group (vildagliptin 50 mg/day as the initial dose).
Other Names:
  • Vilda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LVEF %
Time Frame: 6 months
echocardiographic measurements
6 months
Sortilin (ng/ml)
Time Frame: 6 months
Serum Biomarkers
6 months
LDL (mg/dl)
Time Frame: 6 months
Lipid profile
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hsCRP (mg/L)
Time Frame: 6 months
Serum Biomarkers
6 months
HbA1c %
Time Frame: 6 months
Glycemic control
6 months
FBG (mg/dl)
Time Frame: 6 Months
Serum level
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Collaborators

Tanta University

Investigators

  • Study Director: Lamiaa Khedr, Prof., Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 10, 2024

Study Registration Dates

First Submitted

March 9, 2024

First Submitted That Met QC Criteria

March 9, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 13, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMBA-VILDA-Response trial.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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