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
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 type-2-diabetes-mellitus
Started Dec 2017
Typical duration for phase_4 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2017
CompletedFirst Posted
Study publicly available on registry
August 21, 2017
CompletedStudy Start
First participant enrolled
December 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2020
CompletedJuly 14, 2020
July 1, 2020
2.4 years
August 14, 2017
July 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
empagliflozin 25 mg
EXPERIMENTALEach patient will take 2 tablets each day to ensure double-blind Treatment. Arm 1: 25 mg/d empagliflozin + hydrochlorothiazide placebo
hydrochlorothiazide 25 mg
EXPERIMENTALEach patient will take 2 tablets each day to ensure double-blind Treatment. Arm 2: 25 mg/d hydrochlorothiazide + empagliflozin placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Profil Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, 41460, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tim Heise, MD
Profil Institut für Stoffwechselforschung GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2017
First Posted
August 21, 2017
Study Start
December 8, 2017
Primary Completion
April 20, 2020
Study Completion
April 20, 2020
Last Updated
July 14, 2020
Record last verified: 2020-07