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NCT03639545

The Effects of Empagliflozin on Arterial Wall Characteristics

Status unknown Phase 4 Last updated 21 August 2018
What this trial tests

Phase 4 trial testing Empagliflozin 25mg in Vascular Stiffness in 120 participants. Status unknown.

Timeline
1 March 2018
Primary endpoint
30 December 2018
30 January 2019

Quick facts

Lead sponsorUniversity Medical Centre Ljubljana
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment120
Start date1 March 2018
Primary completion30 December 2018
Estimated completion30 January 2019
Sites1 location across Slovenia

Drugs / interventions tested

Conditions studied

Sponsor

University Medical Centre Ljubljana

Who can join

Adults 30 to 65, any sex, with Vascular Stiffness or Hypoglycemic Agents. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: Diabetes mellitus is characterized by impaired arterial function and high incidence of cardiovascular events. Metformin and most recent antidiabetic groups of drugs, SGLT2 inhibitors, were in previous studies shown to reduce cardiovascular events. Until now, direct effect of empagliflozin on arterial function and its comparison to metformin was not studied yet. Aim: The aim of the present study is to explore and compare potential direct effects of empagliflozin and metformin on arterial functional and structural arterial wall characteristics in patients with type 1 diabetes mellitus. Methods: Patients with type 1 diabetes mellitus are randomized into four groups: 1) empagliflozin (25 mg daily), 2) metformin (2000 mg daily), 3) combination (empagliflozin 25 mg daily and metformin 2000 mg daily) and 4) control (placebo). At inclusion and after 12 weeks treatment, arterial function is assessed: endothelial function (brachial artery flow-mediated dilation (FMD), reactive hyperemia index (RHI)) and arterial stiffness (carotid pulse wave velocity (PWV), carotid-femoral PWV (cfPWV) and common carotid artery stiffness (β-stiffness)).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Empagliflozin on top of metformin treatment improves arterial function in patients with type 1 diabetes mellitus.
    Lunder M, Janić M, Japelj M, Juretič A, et al · · 2018 · cited 73× · PMID 30509271 · DOI 10.1186/s12933-018-0797-6
  2. Empagliflozin-Metformin Combination Has Antioxidative and Anti-Inflammatory Properties that Correlate with Vascular Protection in Adults with Type 1 Diabetes.
    Janić M, Cankar M, Šmid J, France Štiglic A, et al · · 2022 · cited 11× · PMID 35620570 · DOI 10.1155/2022/6796470
  3. Glucometabolic Efficacy of the Empagliflozin/Metformin Combination in People with Type 1 Diabetes and Increased Cardiovascular Risk: A Sub-Analysis of a Pilot Randomized Controlled Trial.
    Janić M, Janež A, Šabović M, El-Tanani M, et al · · 2024 · cited 2× · PMID 39598003 · DOI 10.3390/jcm13226860

Verify or expand the search:

Other trials of Empagliflozin 25mg

Trials testing the same drug.

Other recruiting trials for Vascular Stiffness

Currently open trials in the same condition.

Other University Medical Centre Ljubljana trials

Trials by the same sponsor.

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