EUCTR2016-000172-19-DE
Active, not recruiting
Phase 1
Empagliflozin as a Modulator of Systemic Vascular Resistance and Cardiac Output in Patients with Type 2 Diabetes - EMPA Hemodynamics
RWTH Aachen University for the Medical Faculty, represented by Center for Transitional & Clinical Research Aachen (CTC-A0 sites44 target enrollmentNovember 21, 2016
ConditionsPatients with Type 2 diabetes mellitusTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsJardiance
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with Type 2 diabetes mellitus
- Sponsor
- RWTH Aachen University for the Medical Faculty, represented by Center for Transitional & Clinical Research Aachen (CTC-A
- Enrollment
- 44
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Type 2 diabetes
- •2\.Serum levels of HbA1c \= 6\.5 %
- •3\.Age \= 18 years
- •4\.Written informed consent prior to study participation
- •5\. Participants of child\-bearing age should use adequate contraception
- •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
Exclusion Criteria
- •1\.Type 1 diabetes
- •2\.Systolic blood pressure \= 180 mmHg, diastolic blood pressure \= 100 mmHg
- •3\.Age \= 75 years
- •4\.Pregnancy and lactating females.
- •5\.Renal impairment (GFR \< 30 ml/min/1\.73 m2\)
- •6\.Liver disease (serum levels of AST, ALT or AP more than three times the upper limit of normal)
- •7\.Uncontrolled thyroid disease
- •8\.Endocrinopathies like Graves’ disease, acromegaly, Cushing’s disease
- •9\.Hypertensive retinopathy or encephalopathy
- •10\.Acute coronary syndrome, stroke or transient ischemic attack in last 6 weeks prior to randomization
Outcomes
Primary Outcomes
Not specified
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