Type 2 diabetes mellitus MedDRA version: 17.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Jardiance
Product Name: Empagliflozin
Product Code: BI 10773
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Empagliflozin
CAS Number: 864070-44-0
Other descriptive name: EMPA
Sponsors
IPPMed – Institut für Pharmakologie und Präventive Medizin GmbH
Eligibility
Sex/Gender
All
Inclusion 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. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 40 kg/m² • Triglyceride levels > 1000 mg/dl • HDL-cholesterol levels 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to analyse the effect of empagliflozin on the microcirculation as assessed by the pulse wave reflection in the peripheral arterial tree (indicative of microvascular changes) with the parameters central (aortic) systolic pressure and pulse pressure, augmentation pressure, forward and backward wave amplitude.;Secondary Objective: The secondary objectives of the trial is to analyse the effects of empagliflozin on -retinal capillary flow at baseline (as key measurement of vascular remodelling in the microcirculation) -retinal capillary flow after flicker-light provoking vasodilation, thus allowing to estimate vasodilatory capacity -inner and outer diameter of small retinal arterioles, thus allowing to estimate pulsed flow in the retinal circulation -Pulse wave velocity -24-h ambulatory blood pressure (brachial and central) and vascular parameters (e.g. PWV) under ambulatory conditions -endothelial dysfunction as assessed by the non-invasive EndoPAT 2000 device. -24-h urine samples (e.g. sodium, potassium, glucose and uric acid excretion) -Albuminuria (urinary albumin to creatinine ratio [UACR]), assessed in the 24-hour urine -cardiovascular and metabolic parameters, i.e. casual blood pressure, fasting plasma glucose and HbA1c;Primary end point(s): Effect of empagliflozin on parameters that are determined by pulse wave reflection in the arterial tree: - central (aortic) systolic pressure, - central (aortic) pulse pressure, - augmentation pressure, - forward wave amplitude and - backward wave amplitude.;Timepoint(s) of evaluation of this end point: After first and second phase of cross-over-design | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effects of empagliflozin on: To evaluate the effect of empagliflozin on - retinal capillary flow at baseline (as key measurement of vascular remodelling in the microcirculation) - retinal capillary flow after flicker-light provoking vasodilation, thus allowing to estimate vasodilatory capacity - inner and outer diameter of small retinal arterioles, thus allowing to estimate pulsed flow in the retinal circulation - Pulse wave velocity - 24-h ambulatory blood pressure (brachial and central) and vascular parameters (e.g. PWV) under ambulatory conditions - endothelial dysfunction as assessed by the non-invasive EndoPAT 2000 device. - 24-h urine samples (e.g. sodium, potassium, glucose and uric acid excretion) - Albuminuria (urinary albumin to creatinine ratio [UACR]), assessed in the 24-hour urine - cardiovascular and metabolic parameters, i.e. casual blood pressure, fasting plasma glucose and HbA1c ;Timepoint(s) of evaluation of this end point: After first and second phase of cross-over-design | — |
Countries
Germany
Contacts
Public ContactClinical Research Unit
Medizinische Klinik 4
Outcome results
None listed