Patients with Type 2 diabetes mellitus
Conditions
Interventions
Trade Name: Jardiance
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PL1
CAS Number: 864070-44-0
Other descriptive name: EMPAGLIFLOZIN
Concentration unit: mg milligram(s)
Concentration t
Sponsors
RWTH Aachen University for the Medical Faculty, represented by Center for Transitional & Clinical Research Aachen (CTC-A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Most important secondary analysis: - Stroke volume (SV) - Stroke volume variation (SVV) - Resting energy expenditure (REE) (measured by indirect calorimetry [CardioCoach CO2]) - respiratory exchange rate (RER) measured by indirect calorimetry [CardioCoach CO2]) - Blood pressure - Sodium excretion in 24 h urine collection (osmolarity, sodium, potassium, creatine, chloride, creatine-clearance, protein, urea nitrogen, magnesium, phosphate, glucose, calcium, uric acid) - Body weight - Heart rate - NT-proBNP and cystatin C - Serum levels of chloride, glucose, HbA1c, glucagon, insulin, total-ketone bodies, ß-hydroxybutyrate, aldosterone and free fatty acid - Serum osmolarity - Change in left ventricular function between baseline and after 12 weeks as determined by 2D and 3D parameter global Strain Rate E - Change in left ventricular diastolic function between baseline and after 12 weeks as determined by standardized parameter E/é and left atrial (LA) volume - Change in left ventricular systolic function by ejection fraction (EF) ;Timepoint(s) of evaluation of this end point: day 1, day 3 and 12 weeks | — |
Countries
Germany
Contacts
Public ContactClinical Trial Center
Center for Transitional & Clinical Research Aachen (CTC-A)
Outcome results
None listed