Effects on blood pressure and central sympathetic nerve traffic by SGLT2-inhibition with empagliflozin compared to hydrochlorothiazide in patients with type 2 diabetes mellitus

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002175-25-DE

Enrollment

Registered

2017-07-26

Start date

2017-09-20

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Jardiance® Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Empagliflozin CAS Number: 864070-44-0 Other descriptive name: EMPAGLIFLOZIN Concentration unit: mg milligram(s) Con

Eligibility

Sex/Gender

All

Inclusion criteria

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 • stable or no antihypertensive treatment • HbA1c = 6.5% and = 10.0% • body mass index > 25 kg/m2 and = 60 mmHg Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: • heart failure NYHA II – IV • eGFR 3 x ULN • signs of a clinically significant infection as judged by the investigator • clinical signs of volume depletion • potassium < 3.5 mmol/l • concomitant drug therapy not allowed in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: To show that BP reduction with empagliflozin treatment is associated with lesser increase in sympathetic nerve traffic when compared to HCT treatment;Secondary Objective: To evaluate changes from baseline to end of study in • office BP • fasting glucose • HbA1c • body weight and body composition • MSNA burst incidence • MSNA burst area • sympathetic and parasympathetic baroreflex function • cardiac Output;Primary end point(s): Change in MSNA burst frequency;Timepoint(s) of evaluation of this end point: from baseline to the end of therapy [burst/min]	—

Measure

Time frame

Main Objective: To show that BP reduction with empagliflozin treatment is associated with lesser increase in sympathetic nerve traffic when compared to HCT treatment;Secondary Objective: To evaluate changes from baseline to end of study in • office BP • fasting glucose • HbA1c • body weight and body composition • MSNA burst incidence • MSNA burst area • sympathetic and parasympathetic baroreflex function • cardiac Output;Primary end point(s): Change in MSNA burst frequency;Timepoint(s) of evaluation of this end point: from baseline to the end of therapy [burst/min]

—

Secondary

Measure	Time frame
Secondary end point(s): Change in • office BP • fasting glucose • HbA1c • body weight • fat mass • lean body mass • MSNA burst incidence [bursts/100 heart beats] • MSNA burst area [arbitrary units/min] • sympathetic baroreflex function • parasympathetic baroreflex function • cardiac output;Timepoint(s) of evaluation of this end point: from baseline to end of therapy	—

Countries

Germany

Contacts

Public ContactProject Management

Profil Institut für Stoffwechselforschung GmbH

empa2@profil.com+4921314018146

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026