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COMPLETEDPHASE2

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

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

NCT03713190•University of Pisa

View on ClinicalTrials.gov

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)

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.

Eligibility

Age

30 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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;
+5 more criteria

Locations (1)

Department of Endocrinology and Metabolism, University of Pisa

Pisa, Italy

Key Dates

Start Date

September 10, 2018

Primary Completion Date

February 15, 2020

Completion Date

March 15, 2020

Last Updated

September 14, 2021

Enrollment

ACTUAL participants

Conditions

End Stage Renal Disease

Interventions

Empagliflozin

COMBINATION_PRODUCT

Placebo

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 14, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

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