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

NCT ID: NCT03713190

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2020-03-15

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Empagliflozin

SGLT-2 inhibitor

Group Type: ACTIVE_COMPARATOR

Empagliflozin

Intervention Type: COMBINATION_PRODUCT

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

A substance without specific pharmacology principles.

Group Type: PLACEBO_COMPARATOR

Empagliflozin

Intervention Type: COMBINATION_PRODUCT

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

Intervention Type: DRUG

A substance without specific pharmacology principles

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Placebo

A substance without specific pharmacology principles

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Prof. Stefano Del Prato

Clinical Resercher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Del prato

Role: PRINCIPAL_INVESTIGATOR

University of Pisa

Locations

Department of Endocrinology and Metabolism, University of Pisa

Pisa, , Italy

Countries

Italy

Other Identifiers

EMPA-1

Identifier Type: -

Identifier Source: org_study_id