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

NCT03713190 | Completed Phase 2

• 1 other identifier: EMPA-1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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)

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  2 hours

Study Arms (2)

Empagliflozin

ACTIVE COMPARATOR

SGLT-2 inhibitor

Combination Product: Empagliflozin

placebo

PLACEBO COMPARATOR

A substance without specific pharmacology principles.

Combination Product: Empagliflozin; Drug: Placebo

Interventions

Empagliflozin 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.

Empagliflozin; placebo

Placebo DRUG

A substance without specific pharmacology principles

placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

Department of Endocrinology and Metabolism, University of Pisa

Pisa, 56124, Italy

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Del prato

  University of Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Resercher

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: October 19, 2018
• Study Start: September 10, 2018
• Primary Completion: February 15, 2020
• Study Completion: March 15, 2020
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

IT (1)