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