Overview

Effect of Empagliflozin on Macrovascular and Microvascular Circulation and on Endothelium Function

Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Treatments:
Empagliflozin
Criteria
Inclusion Criteria:

- Type 2 diabetes mellitus defined by fasting glucose ≥ 126 mg/dl or HbA1c ≥ 6.5% or on
blood glucose lowering medication

- Age of 18 - 75 years

- Male and Female patients (females of child bearing potential must be using adequate
contraceptive precautions)

- Females of childbearing potential or within two years of the menopause must have a
negative urine pregnancy test at screening visit

- Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form.

Exclusion Criteria:

- Any other form of diabetes mellitus than type 2 diabetes mellitus

- Use of insulin, glitazone, gliptine or SGLT-2 inhibitor within the past 3 months

- Patients with more than one oral blood glucose lowering medication

- Any other oral antidiabetic drug that cannot be discontinued for the study period

- HbA1c ≥ 10%

- Fasting plasma glucose > 240 mg/dl

- Any history of stroke, transient ischemic attack, instable angina pectoris, or
myocardial infarction within the last 6 months prior to study inclusion

- UACR ≥ 300 mg/g (early morning spot urine)

- eGFR < 60 ml/min/1.73m²

- Uncontrolled arterial hypertension (RR ≥ 180/110 mmHg)

- Congestive heart failure (CHF) NYHA stage III and IV

- Severe disorders of the gastrointestinal tract or other diseases which interfere the
pharmacodynamics and pharmakinetics of study drugs

- Significant laboratory abnormalities such as SGOT or SGPT levels more than 3 x above
the upper limit of normal range

- Drug or alcohol abusus

- Pregnant or breast-feeding patients

- Use of loop diuretics

- History of repetitive urogenital infection per year

- Body mass index > 40 kg/m²

- Triglyceride levels > 1000 mg/dl

- HDL-cholesterol levels < 25 mg/dl

- Any patient currently receiving chronic (>30 consecutive days) treatment with an oral
corticosteroid

- History of epilepsia or history of seizures

- Patients being treated for severe auto immune disease e.g. lupus

- Participation in another clinical study within 30 days prior to visit 1

- Individuals at risk for poor protocol or medication compliance

- Subject who do not give written consent, that pseudonymous data will be transferred in
line with the duty of documentation and the duty of notification according to § 12 and
§ 13 GCP-V