The Effects of Empagliflozin on Arterial Wall Characteristics

NCT03639545 | Unknown Phase 4

• 1 other identifier: AGE-SGLT2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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)).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Arterial function

  Endothelial function and arterial stiffness will be measured.

  the change of arterial function from baseline to 12 weeks of treatment

Secondary Outcomes (1)

• Glycemic control

  the change of HbA1c from baseline to 12 weeks of treatment

Study Arms (4)

*empagliflozin*

ACTIVE COMPARATOR

empagliflozin 25 mg daily for 12 weeks, once daily, by mouth

Drug: Empagliflozin 25mg

*metformin*

ACTIVE COMPARATOR

metformin 2000 mg daily for 12 weeks, once daily, by mouth

Drug: Metformin

*empagliflozin/metformin*

ACTIVE COMPARATOR

empagliflozin 25 mg daily and metformin 2000 mg daily for 12 weeks, by mouth

Drug: Empagliflozin 25mg; Drug: Metformin; Drug: Empagliflozin/Metformin

*placebo*

PLACEBO COMPARATOR

placebo for 12 weeks, once daily with water, by mouth

Drug: Placebos

Interventions

Empagliflozin 25mg DRUG

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

Also known as: empagliflozin

*empagliflozin*; *empagliflozin/metformin*

Metformin DRUG

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

*empagliflozin/metformin*; *metformin*

Empagliflozin/Metformin DRUG

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

Also known as: empagliflozin and metformin

*empagliflozin/metformin*

Placebos DRUG

The patients receive for 12 weeks.

Also known as: placebo

*placebo*

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetes mellitus type 1

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, SI-1000, Slovenia

RECRUITING

Related Publications (1)

• Lunder M, Janic M, Japelj M, Juretic A, Janez A, Sabovic M. Empagliflozin on top of metformin treatment improves arterial function in patients with type 1 diabetes mellitus. Cardiovasc Diabetol. 2018 Dec 3;17(1):153. doi: 10.1186/s12933-018-0797-6.

  PMID: 30509271 DERIVED

MeSH Terms

Conditions

Diabetes Complications; Diabetes Mellitus, Type 1

Interventions

empagliflozin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Andrej Janez, prof

  University Medical Centre Ljubljana

  STUDY CHAIR

Central Study Contacts

Mojca Lunder, MD, PhD

CONTACT

+38615223140; mojca.lunder@kclj.si

Miodrag Janic, MD, PhD

CONTACT

+38615228012; miodrag.janic@kclj.si

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Research assistant at the Department of Endocrinology, Diabetes and Metabolic Diseases

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 21, 2018
• Study Start: March 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: January 30, 2019
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)