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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03713190

Enrollment

Registered

2018-10-19

Start date

2018-09-10

Completion date

2020-03-15

Last updated

2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

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)

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.

Interventions

COMBINATION_PRODUCTEmpagliflozin

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.

DRUGPlacebo

A substance without specific pharmacology principles

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

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; 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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026