End Stage Renal DiseasePhase 2NCT03713190
Effects of Empagliflozin on Endogenous Glucose Production in End Stage Renal Disease(ESRD).
A Phase 2 study testing Empagliflozin in people with End Stage Renal Disease, run by University of Pisa at 1 site in Italy.
Trial 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) Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Empagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 10 Sep 2018to 15 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Endocrinology and Metabolism, University of Pisa
Pisa, 56124
About this study
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
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)
Read the 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
- Being tested
- Empagliflozin, Placebo
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinCombination 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.
PlaceboDrug
A substance without specific pharmacology principles
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Active comparator | SGLT-2 inhibitor Receives: Combination Product: Empagliflozin |
| placebo | Placebo comparator | A substance without specific pharmacology principles. Receives: Combination Product: Empagliflozin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start10 Sep 2018
- Primary completion15 Feb 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Stefano Del Prato, University of Pisa
- Investigators
- Stefano Del prato, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713190
- Sponsor's protocol ID
- EMPA-1
- Status last verified
- Sep 2021
- First submitted
- 18 Jul 2018
- Last updated
- 14 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03713190
- Acronym / sponsor ID
- EMPA-1
- Conditions
- End Stage Renal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Active comparator | Combination Product: EmpagliflozinSGLT-2 inhibitor |
| placebo | Placebo comparator | Combination Product: Empagliflozin, Drug: PlaceboA substance without specific pharmacology principles. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinSodium-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. | Combination product | Empagliflozin, placebo |
| PlaceboA substance without specific pharmacology principles | Drug | placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
Related trials for End Stage Renal Disease
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Safety and Efficacy of Empagliflozin in Hemodialysis
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A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Del prato principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin in people with End Stage Renal Disease, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in plasma Glucose level (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.