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SGLT2 Inhibition and Left Ventricular Mass

NCT02728453 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-03-22

No results posted yet for this study

Summary

Patients with type 2 diabetes mellitus are exposed to an excessive heart failure risk secondary to left ventricular hypertrophy and impaired diastolic filling, a condition not addressed by currently available treatments. The abnormality results from obesity-induced volume overload, increased blood pressure, and myocardial fat accumulation. By improving metabolism, body weight, and blood pressure, Empagliflozin addresses the root causes of type 2 diabetes-associated myocardial disease. We will assess left ventricular mass, function, and lipid content in patients with type 2 diabetes mellitus using cardiac magnetic resonance imaging and spectroscopy as well as echocardiography before and after empagliflozin or glimepiride treatment. We expect to observe improvements in left ventricular mass, function, and fat content with empagliflozin. The results of the study will help to position empagliflozin as an antidiabetic agent with the added value of protecting the heart.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

Empagliflozin

Treatment with empagliflozin vs. glimepiride to understand whether empagliflozin may reduce left ventricular mass in patients with type 2 Diabetes mellitus.

DRUG

Glimepiride

Treatment with empagliflozin vs. glimepiride to understand whether empagliflozin may reduce left ventricular mass in patients with type 2 Diabetes mellitus.

Sponsors & Collaborators

Principal Investigators

  • Jens Jordan, Prof. Dr. · Hannover Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-27
Primary Completion
2017-09-25
Completion
2017-09-27

Countries

  • Germany

Study Locations

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Entities

Companies

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 NCT02728453 on ClinicalTrials.gov