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Trial record 67 of 670 for:    diabetes AND Hypoglycemic | Recruiting, Not yet recruiting, Available Studies

The Effects of Empagliflozin on Arterial Wall Characteristics

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ClinicalTrials.gov Identifier: NCT03639545
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Mojca Lunder, University Medical Centre Ljubljana

Brief 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)).


Condition or disease Intervention/treatment Phase
Vascular Stiffness Hypoglycemic Agents Diabetes Complications Diabetes Mellitus, Type 1 Drug: Empagliflozin 25mg Drug: Metformin Drug: Empagliflozin/Metformin Drug: Placebos Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Empagliflozin on Functional and Structural Arterial Wall Characteristics
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: *empagliflozin*
empagliflozin 25 mg daily for 12 weeks, once daily, by mouth
Drug: Empagliflozin 25mg
The patients receive empagliflozin (25 mg daily) for 12 weeks.
Other Name: empagliflozin

Active Comparator: *metformin*
metformin 2000 mg daily for 12 weeks, once daily, by mouth
Drug: Metformin
The patients receive metformin (2000 mg daily) for 12 weeks.

Active Comparator: *empagliflozin/metformin*
empagliflozin 25 mg daily and metformin 2000 mg daily for 12 weeks, by mouth
Drug: Empagliflozin 25mg
The patients receive empagliflozin (25 mg daily) for 12 weeks.
Other Name: empagliflozin

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.
Other Name: empagliflozin and metformin

Placebo Comparator: *placebo*
placebo for 12 weeks, once daily with water, by mouth
Drug: Placebos
The patients receive for 12 weeks.
Other Name: placebo




Primary Outcome Measures :
  1. Arterial function [ Time Frame: the change of arterial function from baseline to 12 weeks of treatment ]
    Endothelial function and arterial stiffness will be measured.


Secondary Outcome Measures :
  1. Glycemic control [ Time Frame: the change of HbA1c from baseline to 12 weeks of treatment ]
    HbA1c will be measured.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diabetes mellitus type 1

Exclusion Criteria:

  • diagnosed advanced heart, kidney or liver failure
  • benign prostatic hyperplasia
  • prostatic carcinoma
  • frequent urinary tract infections
  • non-type 1 diabetes mellitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639545


Contacts
Contact: Mojca Lunder, MD, PhD +38615223140 mojca.lunder@kclj.si
Contact: Miodrag Janic, MD, PhD +38615228012 miodrag.janic@kclj.si

Locations
Slovenia
University Medical Centre Ljubljana Recruiting
Ljubljana, Slovenia, SI-1000
Contact: Mojca Lunder, MD, PhD    +386 1 5223140    mojca.lunder@kclj.si   
Contact: Andrej Janez, Prof    +386 1 5223564    andrej.janez@kclj.si   
Principal Investigator: Miodrag Janic, MD, PhD         
Principal Investigator: Miso Sabovic, Prof         
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Study Chair: Andrej Janez, prof University Medical Centre Ljubljana

Responsible Party: Mojca Lunder, MD, PhD, Research assistant at the Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03639545     History of Changes
Other Study ID Numbers: AGE-SGLT2
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Complications
Hypoglycemic Agents
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Empagliflozin
Metformin
Physiological Effects of Drugs