- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03254849
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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North Rhine-Westphalia
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Neuss, North Rhine-Westphalia, Germany, 41460
- Profil Institut für Stoffwechselforschung GmbH
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
1 tablet
Other Names:
|
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
|
1 tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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