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

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Empagliflozin
Placebo
Sponsored by
University of Pisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Endocrinology and Metabolism, University of Pisa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Empagliflozin

placebo

Arm Description

SGLT-2 inhibitor

A substance without specific pharmacology principles.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 18, 2018
Last Updated
September 13, 2021
Sponsor
University of Pisa
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1. Study Identification

Unique Protocol Identification Number
NCT03713190
Brief Title
Effects of Empagliflozin on Endogenous Glucose Production in End Stage Renal Disease(ESRD).
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pisa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Empagliflozin
Arm Type
Active Comparator
Arm Description
SGLT-2 inhibitor
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
A substance without specific pharmacology principles.
Intervention Type
Combination Product
Intervention Name(s)
Empagliflozin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A substance without specific pharmacology principles
Primary Outcome Measure Information:
Title
Changes in plasma Glucose level
Description
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.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Del prato
Organizational Affiliation
University of Pisa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology and Metabolism, University of Pisa
City
Pisa
ZIP/Postal Code
56124
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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