Visual Universitätsmedizin Mainz

EmDia

Prospective, randomized, double-blind, placebo-controlled, 2-arm, parallel-group, add-on standard therapy, confirmatory study

  • Study director:

    • Univ.-Prof. Dr. med. Philipp Wild, M.Sc.

Subject

A single-center, randomized, double-blind, placebo-controlled, parallel-group phase IV study on the effects of Empagliflozin on left ventricular diastolic function compared to usual treatment of patients with type 2 diabetes

Study design

Prospective, randomized, double-blind, placebo-controlled, 2-arm, parallel-group, add-on standard therapy, confirmatory study

Study participants

Adults with difficult to control type 2 diabetes

Status

Recruiting finished, Analysis

Objectives

The primary objective of EmDia is to investigate whether oral Empagliflozin treatment after 12 weeks, in addition to standard diabetes therapy or dietary treatment, improves cardiac diastolic function in individuals with type 2 diabetes mellitus.

Study procedure

Patients will be treated for 12 weeks with either Empagliflozin or placebo in addition to their background medication or dietary treatment.

Summary

The incidence of CHF is several times higher in people with type 2 diabetes than in non-diabetics. Poor glycemic control is an important predictor for the development of CHF.

Previous results suggest that Empagliflozin added to standard therapy has a positive impact on cardiovascular outcomes and hospitalization for heart failure in individuals with diabetic mellitus. Because left ventricular diastolic dysfunction is thought to represent the first stage of diabetic cardiomyopathy, the focus of the study is the E/E ratio as a noninvasive surrogate measured by 2D echocardiography for left diastolic pressure with the diagnosis of heart failure.

Based on strong evidence of clinical benefit of Empagliflozin outside of glycemic control, the objective of the EmDia study is to evaluate the effects of Empagliflozin on cardiovascular function compared to placebo and cardiac biomarkers in patients with type 2 diabetes with standard therapy, elevated E/E' ratio and poor glycemic control.

There is still a large knowledge gap regarding the morphological and functional effects of Empagliflozin, independent of its glucose-lowering properties. Therefore, another objective of the study is to establish a biobank to investigate the association between Empagliflozin therapy and biomarker changes during the treatment period, as well as to investigate the association between biomarkers and diabetic complications, cardiovascular disease and their risk factors (metabolism).

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