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Clinical Trials/NCT03131232
NCT03131232
Unknown
Not Applicable

The Aim of This Study is to Investigate the Protective Effect of Empagliflozin on the Cardiovascular System in Diabetes Mellitus Patients

RWTH Aachen University0 sites46 target enrollmentDecember 10, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
RWTH Aachen University
Enrollment
46
Primary Endpoint
The effect of empagliflozine on glucose metabolism
Last Updated
9 years ago

Overview

Brief Summary

In summary, the registry should provide novel insight into potential mechanisms of cardiovascular risk reduction in patients treated with Empagliflozin with an indication of intensified glucose lowering therapy based on their HbA1c level.

Detailed Description

Patients with diabetes exhibit an increased risk for the development of cardiovascular disease with a significantly impaired prognosis compared to patients without diabetes. Recent data from the EMPA-REG Outcome Trial suggest that treatment with the SGLT-2 inhibitor Empagliflozin reduces cardiovascular events, cardiovascular mortality as well as hospitalization for heart failure in patients with type 2 diabetes and pre-existing cardiovascular disease. Empagliflozin leads to reduction of blood glucose by an increased glucose excretion reduces blood pressure and weight. Still, it remains unclear how empagliflozin led to this pronounced reduction of cardiovascular mortality the EMPA-REG OUTCOME trial. Thus, our registry will analyse various biochemical as well as clinical markers in patients with type 2 diabetes and newly initiated treatment with empagliflozin. and an indication for intensification of glucose lowering therapy with empagliflozin. Patients with an indication for an intensified glucose-lowering therapy (HbA1c \> 7,5%) will receive 10 mg empagliflozin and we will perform biochemical analyses of blood samples including insulin, glucagon as well as metabolites at baseline as well as after 1 and 6 months. In addition we will assess echocardiographical data.

Registry
clinicaltrials.gov
Start Date
December 10, 2015
End Date
December 31, 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diabetes mellitus II Patients with whom an empagliflozine treatment is to be initiated from a clinical indication

Exclusion Criteria

  • Inability to consent to the study

Outcomes

Primary Outcomes

The effect of empagliflozine on glucose metabolism

Time Frame: 6 month

NT-pro BNP in pg/ml

Secondary Outcomes

  • Lipid measurements(6 month)
  • Frequency of urinary and urogenital infections(6 month)
  • detection differential regulation of endogenous and exogenous metabolites in addition to circulating proteins by empagliflozin.(6 month)
  • - echocardiographic parameters (if collected) with determination of the systolic and diastolic left ventricular function(6 month)

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