Empagliflozin and Sympathetic Nerve Traffic

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Empagliflozin; Drug: Hydrochlorothiazide 25 mg

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Neuss, North Rhine-Westphalia, Germany, 41460
      • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: empagliflozin 25 mg; Each patient will take 2 tablets each day to ensure double-blind Treatment. Arm 1: 25 mg/d empagliflozin + hydrochlorothiazide placebo	Drug: Empagliflozin; 1 tablet; Other Names: Jardiance
Experimental: hydrochlorothiazide 25 mg; Each patient will take 2 tablets each day to ensure double-blind Treatment. Arm 2: 25 mg/d hydrochlorothiazide + empagliflozin placebo	Drug: Hydrochlorothiazide 25 mg; 1 tablet; Other Names: HCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Profil Institut für Stoffwechselforschung GmbH

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2017
• Primary Completion (Actual): April 20, 2020
• Study Completion (Actual): April 20, 2020

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium-Glucose Transporter 2 Inhibitors; Sodium Chloride Symporter Inhibitors; Empagliflozin; Hydrochlorothiazide
• Other Study ID Numbers: 00/0764-Empa2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No