drugset / Trial / NCT02728453

SGLT2 Inhibition and Left Ventricular Mass

NCT02728453

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Empagliflozin Small molecule 25 mg
Comparator Glimepiride Small molecule 2 mg
Comparator Glimepiride Small molecule 4 mg