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

Phase 1

• Conditions: type 2 diabetes mellitus; MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-002175-25-DE
• Lead Sponsor: Profil Institut für Stoffwechselforschung GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-26
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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 < 40 kg/m²
• systolic blood pressure between 110 mm Hg and 160 mm Hg and diastolic blood pressure >= 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

• heart failure NYHA II – IV
• eGFR < 60 ml/min/1.73 m²
• patients with prior severe cardiovascular disease (MI, stroke, vascular intervention) within the last 12 months
• patients with a history of ketoacidosis
• patients with frequent genital and lower urinary tract infections
• acute and chronic liver disease or screening alanine transaminase or aspartate transaminase > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>•office BP<br>•fasting glucose<br>•HbA1c<br>•body weight and body composition<br>•MSNA burst incidence<br>•MSNA burst area<br>•sympathetic and parasympathetic baroreflex function<br>•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 Outcome Measures

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