Measurement of the effect of Empagliflozin versus Placebo in patients with end-stage renal disease(ESRD).

Phase 1

• Conditions: Patients with end-stage renal disease (ESRD) with or without Type 2 diabetes; MedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 21.1Level: LLTClassification code 10014647Term: End stage renal failureSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-002268-15-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Males and females
2.Age = 30-70 years
3.BMI< 40 Kg/m2 and stable weight (± 3 lbs) over the preceding three months
4.Normal Glucose Tolerance (HbA1c > 4.5 % and < 5.7%) or Type 2 diabetes (HbA1c > 5.7 % and <10.0%)
5.End Stage Renal Disease (GFR <15 ml/min/1.73 m2 or hemodialysis)
6.Subjects are capable of giving informed consent

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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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 <3 yrs
12.blood pressure >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>;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 Outcome Measures

Name	Time	Method
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<br><br>