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Empagliflozin and Sympathetic Nerve Traffic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03254849
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : March 22, 2019
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Empagliflozin Drug: Hydrochlorothiazide 25 mg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 8, 2017
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine

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 Name: 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 Name: HCT

Primary Outcome Measures :
  1. Blood Pressure reduction [ Time Frame: 6 weeks ]
    Blood pressure reduction with empagliflozin treatment is associated with lesser increase in sympathetic nerve traffic when compared to Hydrochlorothiazide treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03254849

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Contact: Maren Lübkert +4921314018 ext 146

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Profil Institut für Stoffwechselforschung GmbH Recruiting
Neuss, North Rhine-Westphalia, Germany, 41460
Contact: Maren Lübkert    +49 2131 4018 146   
Principal Investigator: Tim Heise, MD         
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
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Principal Investigator: Tim Heise, MD Profil Institut für Stoffwechselforschung GmbH

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Responsible Party: Profil Institut für Stoffwechselforschung GmbH Identifier: NCT03254849     History of Changes
Other Study ID Numbers: 00/0764-Empa2
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium-Glucose Transporter 2 Inhibitors
Hypoglycemic Agents