The Effect of Empagliflozin on Glucose Metabolism, Weight, Blood Pressure and Cardiac Function (NT-proBNP) Should be Investigated

Diabetes Mellitus, Type 2 Clinical Trial

— Empa  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03131232
• Other study ID #: 15-152
• Status: Active, not recruiting
• Phase: N/A
• First received: April 13, 2017
• Last updated: April 24, 2017
• Start date: December 10, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2017
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: December 31, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of empagliflozine on glucose metabolism	HbA1c in %	6 month
Primary	The effect of empagliflozine on glucose metabolism	Body weight in kg	6 month
Primary	The effect of empagliflozine on glucose metabolism	BMI in kg/m²	6 month
Primary	The effect of empagliflozine on glucose metabolism	blood pressure in mmHg	6 month
Primary	The effect of empagliflozine on glucose metabolism	NT-pro BNP in pg/ml	6 month
Secondary	Frequency of urinary and urogenital infections	Urinary infection as reported by the patient CRP (Creactive protein) in mg/dl	6 month
Secondary	detection differential regulation of endogenous and exogenous metabolites in addition to circulating proteins by empagliflozin.	perform metabolomic and proteomic profiling of serum samples	6 month
Secondary	Lipid measurements	LDL-C in mg/dl HDL-C in mg/dl TG (triglyceride) in mg/dl	6 month
Secondary	- echocardiographic parameters (if collected) with determination of the systolic and diastolic left ventricular function	LV-EF (left ventricular ejection fraction) in % LV (left ventricular) global strain	6 month