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

End Stage Renal Disease Clinical Trial

Official title:

A Phase II,Randomized,Cross-over,Double-blind, Placebo- Controlled,Single Center Study of the Effect of Empagliflozin a SGLT-2 Inhibitor,on Endogenous Glucose Production and Plasma Glucagon Levels in Patients With ESRD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03713190
• Other study ID #: EMPA-1
• Status: Completed
• Phase: Phase 2
• Start date: September 10, 2018
• Est. completion date: March 15, 2020

Study information

• Verified date: September 2021
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

The impact of SGLT-2 inhibition on endogenous glucose production and plasma glucagon levels will be compared measured in patients with ESRD.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 15, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Combination Product:
• Empagliflozin
Sodium-glucose co-transporter 2 (SGLT2), a low-affinity, high-capacity member of an increasingly numerous family of co-transporters, is highly expressed in the proximal renal tubule, and account for the majority of the reabsorption of filtered glucose.

Drug:
• Placebo
A substance without specific pharmacology principles

Locations

Country	Name	City	State
Italy	Department of Endocrinology and Metabolism, University of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plasma Glucose level	Because of their mechanism of action, SGLT-2 inhibitor efficacy to reduce plasma glucose level is highly dependent upon renal function. With GFR decreasing, glucose tubular load will decrease and less glucose will be reabsorbed because of SGLT2-inhibition.	2 hours