Effect of Empagliflozin on Systemic Vascular Resistance and Cardiac Output in Patients with Type 2 Diabetes
- Conditions
- Patients with Type 2 diabetes mellitusTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2016-000172-19-DE
- Lead Sponsor
- RWTH Aachen University for the Medical Faculty, represented by Center for Transitional & Clinical Research Aachen (CTC-A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 44
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
F.1.3.1 Number of subjects for this age range 10
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
11.The subject is mentally or legally incapacitated
12.The subject received an investigational drug within 30 days prior to inclusion into this study
13. Urinary tract infections or significant formation of residual urine in medical history
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Effect of empagliflozin 10 mg once daily on cardiac output in comparison to placebo after 1 day, 3 days and 12 weeks of treatment (measured with a noninvasive monitoring [ClearSight System]).;Secondary Objective: Not applicable;Primary end point(s): Effect of Empagliflozin 10 mg once daily on systemic vascular resistance in comparison to placebo after day 1, day 3 and 12 weeks of treatment (measured with a noninvasive monitoring [ClearSight System]);Timepoint(s) of evaluation of this end point: day 1, day 3 and 12 weeks
- Secondary Outcome Measures
Name Time Method