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

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ClinicalTrials.gov Identifier: NCT03713190
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Stefano Del Prato, 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)

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Combination Product: Empagliflozin Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Empagliflozin
SGLT-2 inhibitor
Combination Product: 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.

Placebo Comparator: placebo
A substance without specific pharmacology principles.
Combination Product: 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.

Drug: Placebo
A substance without specific pharmacology principles




Primary Outcome Measures :
  1. Changes in plasma Glucose level [ Time Frame: 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.



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713190


Contacts
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Contact: Giuseppe Daniele +3905099503 ext +3905099503 segreteriadiabetologia@ao-pisa.toscana.it
Contact: Stefano Del prato +3905099503 ext +3905099503 segreteriadiabetologia@ao-pisa.toscana.it

Locations
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Italy
Department of Endocrinology and Metabolism, University of Pisa Recruiting
Pisa, Italy, 56124
Contact: Stefano Del Prato, MD    +39 050 995103    stefano.delprato@med.unipi.it   
Sub-Investigator: Giuseppe Daniele, MD         
Sponsors and Collaborators
University of Pisa
Investigators
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Principal Investigator: Stefano Del prato University of Pisa

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Responsible Party: Prof. Stefano Del Prato, Clinical Resercher, University of Pisa
ClinicalTrials.gov Identifier: NCT03713190     History of Changes
Other Study ID Numbers: EMPA-1
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

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

Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs