Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-02 @ 5:23 AM
Study NCT ID:
NCT03131232
Status:
UNKNOWN
Last Update Posted:
2017-04-27
First Post:
2017-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Empagliflozin on Glucose Metabolism, Weight, Blood Pressure and Cardiac Function (NT-proBNP) Should be Investigated
Sponsor:
RWTH Aachen University
Organization:
Study Overview
Official Title:
The Aim of This Study is to Investigate the Protective Effect of Empagliflozin on the Cardiovascular System in Diabetes Mellitus Patients
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Empa
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: