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

Phase 2

Completed

• Conditions: End Stage Renal Disease
• Interventions: Combination Product: Empagliflozin; Drug: Placebo

• Registration Number: NCT03713190
• Lead Sponsor: University of Pisa

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.

Study Timeline

• Study First Submitted: 2018-07-18
• Study Start: 2018-09-10
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-19
• Primary Completion: 2020-02-15
• Study Completion: 2020-03-15
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
placebo	Empagliflozin	A substance without specific pharmacology principles.
Empagliflozin	Empagliflozin	SGLT-2 inhibitor
placebo	Placebo	A substance without specific pharmacology principles.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Endocrinology and Metabolism, University of Pisa; 🇮🇹 Pisa, Italy