EUCTR2017-002175-25-DEActive, not recruitingPhase 1
Effects on blood pressure and central sympathetic nerve traffic by SGLT2-inhibition with empagliflozin compared to hydrochlorothiazide in patients with type 2 diabetes mellitus
Profil Institut für Stoffwechselforschung GmbH0 sites60 target enrollmentStarted: July 26, 2017Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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