Empagliflozin and Sympathetic Nerve Traffic

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Effects on Blood Pressure and Central Sympathetic Nerve Traffic by SGLT2-inhibition With Empagliflozin Compared to Hydrochlorothiazide in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254849
• Other study ID #: 00/0764-Empa2
• Status: Completed
• Phase: Phase 4
• Start date: December 8, 2017
• Est. completion date: April 20, 2020

Study information

• Verified date: July 2020
• Source: Profil Institut für Stoffwechselforschung GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study the effects of the Inhibition of the Sodium-Glucose Linked Transporter 2 in the kidney with empagliflozin compared to hydrochlorothiazide on blood pressure and on central sympathic nervous activity will be examined.

Description:

The drug empagliflozin is a selective oral inhibitor of the sodium-glucose co-transporter 2 (SGLT-2) in the kidney.On the market empagliflozin is approved for the treatment of type 2 Diabetes. The mechanism of action can be described as follows: SGLT-2 is responsible for 90% of the reabsorption of Glucose in the kidney. If this Transport System is inhibited the secretion of glucose via the urine is increased. Therefore the blood glucose concentration will be lowered.

It has been noted that the SGLT-2 drugs are lowering the blood pressure as well, but the specific characteristics of the durg leading to this effect have not been examined in adequate clinical trial up to now.

To evaluate the central sympathic nervous activity a microneurography will be performed in this study; this examination will provide Information if empagliflozin dose decrease the sympathic nervous activity. If this is the case new effects of empagliflozin have to be discussed, Otherwise it can be assumed that the blood pressure decrease is a result of an increase of urine volume. In this case the sympathic activity should be increased.

This study will be performed in parallel groups who will receive a double-blind, randomised treatment, either empagliflozin or hydrochlorothiazide. The hypothesis that empagliflozin - in contrast to hydrochlorthiazide - does not increase the sympathic nervous activity in obese, hypertensive subjects with type 2 Diabetes treated with metformin will be tested.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 20, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• women and men >= 50 and <= 80 years of age

• type 2 diabetes mellitus for >=2 years

• only metformin monotherapy is allowed; metformin dose must have been stable for >=12 weeks

Exclusion Criteria:

• previous empagliflozin treatment within the last 3 months

• heart failure NYHA II - IV

• subjects who have received any investigational medicinal product or have used any investigational medical device within 30 days prior to the screening visit, or who are actively participating in any investigational medicinal product or medical device trial, or who are scheduled for any such trial during the course of the trial.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Empagliflozin
1 tablet
• Hydrochlorothiazide 25 mg
1 tablet

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Profil Institut für Stoffwechselforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure reduction	Blood pressure reduction with empagliflozin treatment is associated with lesser increase in sympathetic nerve traffic when compared to Hydrochlorothiazide treatment	6 weeks