Patients with end-stage renal disease (ESRD) with or without Type 2 diabetes MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 21.1 Level: LLT Classification code 10014647 Term: End stage renal failure System Organ Class: 100000004857
Conditions
Interventions
Trade Name: JARDIANCE - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 28 COMPRESSE
Product Name: JARDIANCE
Product Code: JARDIANCE
Pharmaceutical Form: Film-coated tablet
IN
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females 2. Age = 30-70 years 3. BMI 4.5 % and 5.7 % and =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Prednisone treatment 2. Insulin, Beta blocker or any medication that affects sympathetic/parasympathetic activity or known to affect glucose metabolism (other than metformin and sulfonylurea) 3. Known Empagliflozin Excipient Hypersensitivity 4. Liver function enzymes higher more than two times the upper limit 5. Ongoing urinary tract infection 6. history of cancer of any type; 7. cerebrovascular or symptomatic peripheral vascular disease; 8. heart disease class III or IV NYHA; 9. Type 1 Diabetes 10. drug or alcohol abuse; 11. life expectancy 150/100 mmHg 13. Donation of blood to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 400 mL of blood during the 8 weeks prior to the enrollment visit and at least 8 weeks thereafter 14. Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment) 15. Patient with a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient or interfere with trial procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that a single empagliflozin (25 mg) oral administration in subjects with ESRD (end-stage renal disease) will stimulate EGP (Endogenous Glucose Production) and increase plasma glucagon concentration as compared to placebo;Secondary Objective: To test the hypothesis that a single empagliflozin (25 mg) oral administration in subjects with ESRD (end-stage renal disease) will modulate plasma glucose, insulin, c-peptide, FFA, GH, epinephrine, norepinephrine, cortisol and blood pressure as compared to placebo;Primary end point(s): The primary endpoint is the mean difference in EGP and plasma glucagon concentration during the last hour of EGP measurement between empagliflozin versus placebo administration in patients with end-stage renal disease;Timepoint(s) of evaluation of this end point: This timepoint will be achieved in a three-year study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are the mean difference in plasma glucose, insulin, c-peptide, FFA, GH, epinephrine, norepinephrine, cortisol and blood pressure during the last hour of the experiment between empagliflozin versus placebo administration in patients with end-stage renal disease;Timepoint(s) of evaluation of this end point: This timepoint will be achieved in a three-year study | — |
Countries
Italy
Contacts
Public ContactUO MALATTIE METABOLICHE E DIABETOLO
UO MALATTIE METABOLICHE E DIABETOLOGIA
Outcome results
None listed