Effects of Empagliflozin on Endogenous Glucose Production in End Stage Renal Disease(ESRD).

• Status: Completed
• Trial end date: 2020-03-15
• Target enrollment: 0
• Participant gender: All

Summary

A study of the effects of empagliflozin, a SGLT-2 inhibitor, on endogenous glucose production and plasma glucagon levels in patients with end-stage renal disease (ESRD)

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pisa
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

1. Males and females

2. Age = 30-70 years

3. BMI< 40 Kg/m 2 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 m 2 or hemodialysis)

6. Subjects are capable of giving informed consent

Exclusion Criteria:

1. Prednisone treatment

2. Beta blocker or any medication that affects sympathetic/parasympathetic activity

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