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

Sponsor

University of Pisa (Other)

Overall Status

Completed

CT.gov ID

NCT03713190

Collaborator

(none)

Enrollment

Location

Arms

18.1

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease	Combination Product: Empagliflozin Drug: Placebo	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 10, 2018

Actual Primary Completion Date :

Feb 15, 2020

Actual Study Completion Date :

Mar 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Empagliflozin SGLT-2 inhibitor	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.
Placebo Comparator: placebo A substance without specific pharmacology principles.	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

Arm

Intervention/Treatment

Active Comparator: Empagliflozin

SGLT-2 inhibitor

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.

Placebo Comparator: placebo

A substance without specific pharmacology principles.

Combination Product: Empagliflozin

Drug: Placebo

A substance without specific pharmacology principles

Outcome Measures

Primary Outcome Measures

Changes in plasma Glucose level [2 hours]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Prednisone treatment
Beta blocker or any medication that affects sympathetic/parasympathetic activity
Known Empagliflozin Excipient Hypersensitivity
Liver function enzymes higher more than two times the upper limit
Ongoing urinary tract infection
history of cancer of any type;
cerebrovascular or symptomatic peripheral vascular disease;
heart disease class III or IV NYHA;
Type 1 Diabetes
drug or alcohol abuse;
life expectancy <3 yrs
blood pressure >150/100 mmHg
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
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)
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Endocrinology and Metabolism, University of Pisa	Pisa		Italy	56124

Sponsors and Collaborators

University of Pisa

Investigators

Principal Investigator: Stefano Del prato, University of Pisa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Stefano Del Prato, Clinical Resercher, University of Pisa

ClinicalTrials.gov Identifier:

NCT03713190

Other Study ID Numbers:

EMPA-1

First Posted:

Oct 19, 2018

Last Update Posted:

Sep 14, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Kidney Diseases

Kidney Failure, Chronic

Empagliflozin

Study Results

No Results Posted as of Sep 14, 2021