Empagliflozin Versus Vildagliptin in CAD Patients With T2DM

NCT06313008 | Completed

• 1 other identifier: EMBA-VILDA-Response trial.
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease; Type 2 Diabetes

Keywords

CAD.; T2DM.; LVEF%.; Sortilin.; Empaglilozin.; Vildagliptin.

Outcome Measures

Primary Outcomes (3)

• LVEF %

  echocardiographic measurements

  6 months

• Sortilin (ng/ml)

  Serum Biomarkers

  6 months

• LDL (mg/dl)

  Lipid profile

  6 months

Secondary Outcomes (3)

• hsCRP (mg/L)

  6 months

• HbA1c %

  6 months

• FBG (mg/dl)

  6 Months

Study Arms (2)

Empagliflozin

EXPERIMENTAL

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

Drug: Empagliflozin 10 MG

Vildagliptin

EXPERIMENTAL

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

Drug: Vildagliptin 50 MG

Interventions

Empagliflozin 10 MG DRUG

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

Also known as: Empa

Empagliflozin

Vildagliptin 50 MG DRUG

eligible subjects were randomly and equally assigned to vildagliptin add-on group (vildagliptin 50 mg/day as the initial dose).

Also known as: Vilda

Vildagliptin

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Damanhour University: lead
• Tanta University: collaborator

Study Sites (1)

Rehab Hussein Werida

Damanhūr, Elbehairah, 31527, Egypt

Location

Related Publications (4)

• Tanaka A, Shimabukuro M, Okada Y, Taguchi I, Yamaoka-Tojo M, Tomiyama H, Teragawa H, Sugiyama S, Yoshida H, Sato Y, Kawaguchi A, Ikehara Y, Machii N, Maruhashi T, Shima KR, Takamura T, Matsuzawa Y, Kimura K, Sakuma M, Oyama JI, Inoue T, Higashi Y, Ueda S, Node K; EMBLEM Trial Investigators. Rationale and design of a multicenter placebo-controlled double-blind randomized trial to evaluate the effect of empagliflozin on endothelial function: the EMBLEM trial. Cardiovasc Diabetol. 2017 Apr 12;16(1):48. doi: 10.1186/s12933-017-0532-8.

  PMID: 28403850 BACKGROUND

• Shimizu W, Kubota Y, Hoshika Y, Mozawa K, Tara S, Tokita Y, Yodogawa K, Iwasaki YK, Yamamoto T, Takano H, Tsukada Y, Asai K, Miyamoto M, Miyauchi Y, Kodani E, Ishikawa M, Maruyama M, Ogano M, Tanabe J; EMBODY trial investigators. Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial. Cardiovasc Diabetol. 2020 Sep 25;19(1):148. doi: 10.1186/s12933-020-01127-z.

  PMID: 32977831 BACKGROUND

• Schernthaner G, Schernthaner-Reiter MH, Schernthaner GH. EMPA-REG and Other Cardiovascular Outcome Trials of Glucose-lowering Agents: Implications for Future Treatment Strategies in Type 2 Diabetes Mellitus. Clin Ther. 2016 Jun;38(6):1288-1298. doi: 10.1016/j.clinthera.2016.04.037. Epub 2016 May 19.

  PMID: 27210264 BACKGROUND

• Naing S, Poliyedath A, Khandelwal S, Sigala T. Impact of EMPA-REG OUTCOME(R) on the management of type 2 diabetes mellitus: a review for primary care physicians. Postgrad Med. 2016 Nov;128(8):822-827. doi: 10.1080/00325481.2016.1245093. Epub 2016 Oct 25.

  PMID: 27701934 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus, Type 2

Interventions

empagliflozin; Vildagliptin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lamiaa Khedr, Prof.

  Tanta University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This was a prospective, randomized, double-dummy, blinded-endpoint, parallel-group trial that enrolled 120 CAD patients with T2DM. The patients were randomized 1: 1 for 6 months administration of empagliflozin or vildagliptin.

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 15, 2024
• Study Start: August 10, 2023
• Primary Completion: September 30, 2024
• Study Completion: October 10, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)