The Effects of Empagliflozin on Arterial Wall Characteristics

Sponsor
University Medical Centre Ljubljana
Study ID
NCT03639545
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 25mg — DRUG
    The patients receive empagliflozin (25 mg daily) for 12 weeks.
  • Metformin — DRUG
    The patients receive metformin (2000 mg daily) for 12 weeks.
  • Empagliflozin/Metformin — DRUG
    The patients receive empagliflozin 25 mg daily and metformin 2000 mg daily or placebo for 12 weeks.
  • Placebos — DRUG
    The patients receive for 12 weeks.

Study Details

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)).

Key Dates

Start date
Mar 1, 2018
Status verified
Aug 2018
Primary completion
Dec 30, 2018
Completion
Jan 30, 2019

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: *empagliflozin*
    empagliflozin 25 mg daily for 12 weeks, once daily, by mouth
  • Active Comparator: *metformin*
    metformin 2000 mg daily for 12 weeks, once daily, by mouth
  • Active Comparator: *empagliflozin/metformin*
    empagliflozin 25 mg daily and metformin 2000 mg daily for 12 weeks, by mouth
  • Placebo Comparator: *placebo*
    placebo for 12 weeks, once daily with water, by mouth

Primary Outcome Measure

Arterial function [ Time Frame: the change of arterial function from baseline to 12 weeks of treatment ]

Central Contacts

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