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The Effects of Empagliflozin on Arterial Wall Characteristics

NCT03639545 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-08-21

No results posted yet for this study

Summary

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)).

Conditions

  • Vascular Stiffness
  • Hypoglycemic Agents
  • Diabetes Complications
  • Diabetes Mellitus, Type 1

Interventions

DRUG

Empagliflozin 25mg

The patients receive empagliflozin (25 mg daily) for 12 weeks.

DRUG

Metformin

The patients receive metformin (2000 mg daily) for 12 weeks.

DRUG

Empagliflozin/Metformin

The patients receive empagliflozin 25 mg daily and metformin 2000 mg daily or placebo for 12 weeks.

DRUG

Placebos

The patients receive for 12 weeks.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Andrej Janez, prof · University Medical Centre Ljubljana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-12-30
Completion
2019-01-30

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03639545 on ClinicalTrials.gov