Effect of Empagliflozin on Macrovascular and Microvascular Circulation and on Endothelium Function
- Sponsor
- University of Erlangen-Nürnberg Medical School
- Study ID
- NCT02471963
- Phase
- PHASE3
- Status
- Completed
Conditions
- Diabetes Mellitus Type 2
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Empagliflozin — DRUG
- Placebo — DRUG
Study Details
Empagliflozin may lead to improved vascular and endothelial function in the macro- (pulse wave reflection) and microcirculation (retinal circulation) and improve cardiovascular risk factors, imparticular by effectively controlling hyperglycemia, arterial hypertension and obesity.
Key Dates
- Start date
- Dec 31, 2014
- Status verified
- May 2018
- Primary completion
- Nov 30, 2015
- Completion
- Jun 30, 2016
Study Design
- Enrollment
- 74 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Active Comparator: EmpagliflozinEmpagliflozin, 25 mg/day, oral administration, 6 weeks
- Placebo Comparator: PlaceboPlacebo, oral administration, 6 weeks
Primary Outcome Measure
Effect of empagliflozin after 6 weeks of treatment on macrocirculation [ Time Frame: 6 weeks ]
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