Type 2 Diabetes MellitusPhase 2ERADICATE-HFNCT03416270

ERtugliflozin triAl in DIabetes With Preserved or Reduced ejeCtion FrAcTion mEchanistic Evaluation in Heart Failure

A Phase 2 study testing Ertugliflozin in people with Type 2 Diabetes Mellitus and Heart Failure, run by University Health Network, Toronto at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to elucidate the mechanisms whereby the SGLT2i "ertugliflozin" modifies cardiorenal interactions that regulate fluid volume and neurohormonal activation in patients with type 2 diabetes and heart failure (T2D-HF). Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Type 2 Diabetes Mellitus, Heart Failure
What is being tested?: Ertugliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 3 sitesin 2 countries
Study dates: 28 Jun 2018to 14 Apr 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects diagnosed with T2D ≥12 months prior to informed consent;
eGFR ≥30 ml/min/1.73m2;
Age >18 years;
HbA1c 6.5%-10.5%;
Body Mass Index (BMI) 18.5-45.0 kg/m2;
Blood pressure ≤160/110 and ≥90/60 at screening,

Show all 10Show fewer

Heart failure with New York Heart Association (NYHA) class 2-3 symptoms and ejection fraction ≥20%
Stable dose of maximally tolerated ACE inhibitor, angiotensin receptor blocker or renin inhibitor for at least 30 days
Stable diuretic dose for at least 30 days at the time of baseline physiological assessment
BNP levels at baseline ≥100 pg/ml (no atrial fibrillation), ≥200 pg/ml if in atrial fibrillation

Who cannot join

Type 1 Diabetes;
Leukocyte and/or nitrite positive urinalysis that is untreated;
Severe hypoglycaemia within 2 months prior to screening;
History of brittle diabetes or hypoglycaemia unawareness based on investigator judgement;
Unstable coronary artery disease with acute coronary syndrome, percutaneous intervention or bypass surgery within 3 months;
Clinically significant valvular disease;

Show all 17Show fewer

Congestive heart failure secondary to an infiltrative cardiomyopathic process (for example amyloid) or pericardial constriction;
Uncontrolled systemic hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >110) or systemic hypotension (systolic blood pressure < 90/60 mmHg);
Bariatric surgery or other surgeries that induce chronic malabsorption;
Anti-obesity drugs or diet regimen and unstable body weight three months prior to screening;
Treatment with systemic corticosteroids;
Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells;
Pre-menopausal women who are nursing, pregnant, or of child-bearing potential and not practicing an acceptable method of birth control;
Participation in another trial with an investigational drug within 30 days of informed consent;
Alcohol or drug abuse within three months prior to informed consent that would interfere with trial participation or any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement;
Liver disease, defined by serum levels of alanine transaminase, aspartate transaminase, or alkaline phosphatase >3 x upper limit of normal as determined during screening;
Active malignancy at the time of screening;

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

Netherlands2 sites

Vanderbilt University Medical Centre
Amsterdam, De Boelelaan, 1117
University Medical Center Groningen
Groningen

Other trials in Netherlands

Canada1 site

Toronto General Hospital
Toronto, Ontario, M5G2N2

Other trials in Canada

About this study

Official title: ERtugliflozin triAl in DIabetes With Preserved or Reduced ejeCtion FrAcTion mEchanistic Evaluation in Heart Failure: "ERADICATE-HF"

Read the detailed description

Newer agents called sodium glucose co-transporter-2 inhibitors (SGLT2i) have been developed to improve glycemic control and lower hemoglobin A1c by increasing glycosuria. SGLT2i also reduce blood pressure and albuminuria in T2D - possibly through natriuresis. Importantly, a landmark trial "EMPA-REG OUTCOME" demonstrated that the SGLT2i "empagliflozin" is the first anti- hyperglycemic agent to reduce mortality and HF risk, and also to decrease the risk of progressive diabetic nephropathy. Similar benefits were also recently reported in the CANVAS Program trial with canagliflozin. Despite the benefits observed in these two pivotal trials, the mechanisms responsible for beneficial effects of SGLT2i in patients with T2D with respect to the development and/or worsening of HF are not currently known.

In light of the results of EMPA-REG OUTCOME, the investigators aim to elucidate the mechanisms whereby the SGLT2i "ertugliflozin" modifies cardiorenal interactions that regulate fluid volume and neurohormonal activation in patients with T2D and HF (T2D-HF). The investigators will test the hypothesis that ertugliflozin increases proximal tubular natriuresis, thereby reducing plasma volume, without inducing significant renal vasoconstriction or activation of the sympathetic nervous system (SNS) (see below, Figure 1). The systematic understanding of the effects of SGLT2i in the setting of HF will enable the design of rational physiology based strategies to decrease the burden of HF, which could have major clinical and research implications internationally.

Conditions: Type 2 Diabetes Mellitus, Heart Failure
Being tested: Ertugliflozin, Placebo
Keywords: SGLT2 inhibtion, Ertugliflozin, Type 2 Diabetes, Heart Failure
Medical subject headings: Diabetes Mellitus, Type 2, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ErtugliflozinDrug
Ertugliflozin Tablets Total Dose 15mg (10mg + 5 mg) once daily for 12 weeks
PlaceboDrug
Placebo once daily for 12 weeks

Study groups in NCT03416270
Study group	Role	What they receive
Ertuglifozin Treatment Arm	Experimental	Ertugliflozin Tablets Total Dose 15mg (10mg + 5 mg) for 12 weeks Receives: Drug: Ertugliflozin
Placebo Arm	Placebo comparator	Placebo Matching Ertugliflozin Tablet for 12 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Fractional Excretion of Lithium (FELi)
The difference in fractional excretion of lithium (FELi) with ertugliflozin vs. placebo. This was measured using exogenous lithium administration 12 hours before lithium excretion was measured in urine and blood.
Measured: Change in outcomes was measured acute (1 week minus baseline values) and chronic (12 weeks minus baseline values)
Fractional Excretion of Sodium (FENa)
The difference in fractional excretion of sodium (FENa) with ertugliflozin vs. placebo. This was measured using exogenous lithium administration 12 hours before sodium excretion was measured in urine and blood.
Measured: Change in outcomes was measured acute (1 week minus baseline values) and chronic (12 weeks minus baseline values)
Change in Absolute Fractional Distal Sodium Reabsorption From Baseline (FELi-FENa)
The difference in fractional excretion of lithium and fractional excretion of sodium (calculated by the difference between FELi and FENa) with ertugliflozin vs. placebo. This was measured using exogenous lithium administration 12 hours before sodium excretion was measured in urine and blood.
Measured: Change in outcomes was measured acute (1 week minus baseline values) and chronic (12 weeks minus baseline values)

Secondary outcomes (15)

Glomerular Filtration Rate (GFR)
The difference in iohexol-measured GFR with ertugliflozin vs. placebo. 5ml bolus iohexol (Omnipaque 300mg) was infused intravenously over 2 minutes while participants were supine. Iohexol disappearance curve was used to measure GFR over from 2-4 hours after infusion.
Measured: Glomerular Filtration Rate (GFR, based on plasma iohexol clearance) will be measured at 12 weeks
Effective Renal Plasma Flow (ERPF)
The difference in ERPF with ertugliflozin vs. placebo. Paraaminohippurate (PAH) was intravenously administered to measured ERPF.
Measured: Effective Renal Plasma Flow (ERPF, based on paraaminohippurate plasma clearance) will be measured at 12 weeks
Systolic Blood Pressure (SBP)
The difference in seated SBP with ertugliflozin vs. placebo
Measured: chronic (12 weeks)
Diastolic Blood Pressure (DBP)
The difference in seated DBP with ertugliflozin vs. placebo
Measured: chronic (12 weeks)
Heart Rate (HR)
The difference in seated HR with ertugliflozin vs. placebo
Measured: chronic (12 weeks)
LV Ejection Fraction
Echocardiography for markers of systolic and diastolic function
Measured: chronic (12 weeks)
Carotid-femoral Pulse Wave Velocity
Arterial Stiffness using SphygmaCor software. Pulse points measured at carotid and femoral arteries.
Measured: chronic (12 weeks)
Plasma Volume
Plasma volume will be measured using a non-radioactive technique (indocyanine green dilution)
Measured: chronic (12 weeks)
Extracellular Water
Extracellular water will be measured non-invasively using bioimpedence spectroscopy
Measured: chronic (12 weeks)
Cardiac Output
Cardiac output will also be measured using non-invasive cardiac monitoring (NICOM)
Measured: chronic (12 weeks)
Systemic Vascular Resistance
Systemic vascular resistance will also be measured using non-invasive cardiac monitoring (NICOM)
Measured: chronic (12 weeks)
Blood Angiotensin II
Neurohormones/biomarkers
Measured: chronic (12 weeks)
BNP
Neurohormones/biomarkers
Measured: chronic (12 weeks)
Norepinephrine
Neurohormones/biomarkers
Measured: chronic (12 weeks)
Urinary Adenosine
Neurohormones/biomarkers
Measured: chronic (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 201814 Apr 2021

First posted31 Jan 2018
Study start28 Jun 2018
Primary completion14 Apr 2021
Study completion14 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by University Health Network, TorontoThe sponsor's other registered studies.
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: Parallel groups
Model description: Patients will be randomized to 15 mg (10mg + 5mg tablets) PO ertugliflozin daily or a matched placebo.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03416270
Sponsor's protocol ID: 17-5627
Acronym: ERADICATE-HF
Status last verified: Apr 2025
First submitted: 15 Jan 2018
Last updated: 6 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ERtugliflozin triAl in DIabetes With Preserved or Reduced ejeCtion FrAcTion mEchanistic Evaluation in Heart Failure: "ERADICATE-HF"
ClinicalTrials.gov ID: NCT03416270
Acronym / sponsor ID: ERADICATE-HF / 17-5627
Conditions: Type 2 Diabetes Mellitus, Heart Failure
Keywords: SGLT2 inhibtion, Ertugliflozin, Type 2 Diabetes, Heart Failure
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: University Health Network, TorontoUniversity, hospital or other
Collaborators: University Medical Center Groningen, Merck Sharp & Dohme LLC, University of Toronto, Toronto General Hospital
Study start: 28 Jun 2018 (actual)
Primary completion: 14 Apr 2021 (actual)
Study completion: 14 Apr 2021 (actual)
First posted: 31 Jan 2018 (actual)
Results: Posted 6 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Patients will be randomized to 15 mg (10mg + 5mg tablets) PO ertugliflozin daily or a matched placebo.

Arm	Type	Receives
Ertuglifozin Treatment Arm	Experimental	Drug: ErtugliflozinErtugliflozin Tablets Total Dose 15mg (10mg + 5 mg) for 12 weeks
Placebo Arm	Placebo comparator	Drug: PlaceboPlacebo Matching Ertugliflozin Tablet for 12 weeks

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male or female subjects diagnosed with T2D ≥12 months prior to informed consent;
eGFR ≥30 ml/min/1.73m2;
Age >18 years;
HbA1c 6.5%-10.5%;
Body Mass Index (BMI) 18.5-45.0 kg/m2;

Key exclusion criteria (17 listed)

Type 1 Diabetes;
Leukocyte and/or nitrite positive urinalysis that is untreated;
Severe hypoglycaemia within 2 months prior to screening;
History of brittle diabetes or hypoglycaemia unawareness based on investigator judgement;
Unstable coronary artery disease with acute coronary syndrome, percutaneous intervention or bypass surgery within 3 months;

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
ErtugliflozinErtugliflozin Tablets Total Dose 15mg (10mg + 5 mg) once daily for 12 weeks	Drug	Ertuglifozin Treatment Arm
PlaceboPlacebo once daily for 12 weeks	Drug	Placebo Arm

Primary outcome

Fractional Excretion of Lithium (FELi)
Time frame: Change in outcomes was measured acute (1 week minus baseline values) and chronic (12 weeks minus baseline values)
The difference in fractional excretion of lithium (FELi) with ertugliflozin vs. placebo. This was measured using exogenous lithium administration 12 hours before lithium excretion was measured in urine and blood.
Fractional Excretion of Sodium (FENa)
Time frame: Change in outcomes was measured acute (1 week minus baseline values) and chronic (12 weeks minus baseline values)
The difference in fractional excretion of sodium (FENa) with ertugliflozin vs. placebo. This was measured using exogenous lithium administration 12 hours before sodium excretion was measured in urine and blood.
Change in Absolute Fractional Distal Sodium Reabsorption From Baseline (FELi-FENa)
Time frame: Change in outcomes was measured acute (1 week minus baseline values) and chronic (12 weeks minus baseline values)
The difference in fractional excretion of lithium and fractional excretion of sodium (calculated by the difference between FELi and FENa) with ertugliflozin vs. placebo. This was measured using exogenous lithium administration 12 hours before sodium excretion was measured in urine and blood.

15 secondary outcomes

Glomerular Filtration Rate (GFR)
Time frame: Glomerular Filtration Rate (GFR, based on plasma iohexol clearance) will be measured at 12 weeks
Effective Renal Plasma Flow (ERPF)
Time frame: Effective Renal Plasma Flow (ERPF, based on paraaminohippurate plasma clearance) will be measured at 12 weeks
Systolic Blood Pressure (SBP)
Time frame: chronic (12 weeks)
Diastolic Blood Pressure (DBP)
Time frame: chronic (12 weeks)
Heart Rate (HR)
Time frame: chronic (12 weeks)
LV Ejection Fraction
Time frame: chronic (12 weeks)
Carotid-femoral Pulse Wave Velocity
Time frame: chronic (12 weeks)
Plasma Volume
Time frame: chronic (12 weeks)
Extracellular Water
Time frame: chronic (12 weeks)
Cardiac Output
Time frame: chronic (12 weeks)
Systemic Vascular Resistance
Time frame: chronic (12 weeks)
Blood Angiotensin II
Time frame: chronic (12 weeks)
BNP
Time frame: chronic (12 weeks)
Norepinephrine
Time frame: chronic (12 weeks)
Urinary Adenosine
Time frame: chronic (12 weeks)

Results and safety

Results posted to the registry on 6 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ertuglifozin Treatment Arm	17	17
Placebo Arm	17	16

Primary outcome: Fractional Excretion of Lithium (FELi)

Time frame: Change in outcomes was measured acute (1 week minus baseline values) and chronic (12 weeks minus baseline values). Mean (Standard Error). Unit: percentage of filtered lithium excreted

Measure	Ertuglifozin Treatment Arm n = 17	Placebo Arm n = 16
Week 1	0.3 (6.9)	-2.3 (16.8)
Week 12	0.8 (11.0)	-4.9 (16.6)

Ertuglifozin Treatment Arm vs Placebo Arm: p = 0.36, Wilcoxon (Mann-Whitney)
Ertuglifozin Treatment Arm vs Placebo Arm: p = 0.56, Wilcoxon (Mann-Whitney)

Primary outcome: Fractional Excretion of Sodium (FENa)

Time frame: Change in outcomes was measured acute (1 week minus baseline values) and chronic (12 weeks minus baseline values). Mean (Standard Error). Unit: percentage of sodium excretion

Measure	Ertuglifozin Treatment Arm n = 17	Placebo Arm n = 16
Week 1	-0.6 (1.9)	0.3 (1.7)
Week 12	-0.6 (1.6)	0.1 (1.3)

Ertuglifozin Treatment Arm vs Placebo Arm: p = 0.53, Wilcoxon (Mann-Whitney)
Ertuglifozin Treatment Arm vs Placebo Arm: p = 0.89, Wilcoxon (Mann-Whitney)

Primary outcome: Change in Absolute Fractional Distal Sodium Reabsorption From Baseline (FELi-FENa)

Time frame: Change in outcomes was measured acute (1 week minus baseline values) and chronic (12 weeks minus baseline values). Mean (Standard Error). Unit: percentage of total sodium reabsorption

Measure	Ertuglifozin Treatment Arm n = 17	Placebo Arm n = 16
Week 1	0.8 (7.0)	-2.6 (16.7)
Week 12	1.4 (10.6)	-5 (16.1)

Ertuglifozin Treatment Arm vs Placebo Arm: p = 0.26, Wilcoxon (Mann-Whitney)
Ertuglifozin Treatment Arm vs Placebo Arm: p = 0.56, Wilcoxon (Mann-Whitney)

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ertuglifozin Treatment Arm	3 of 17 (17.6%)	0 of 17 (0%)	0 of 17
Placebo Arm	1 of 17 (5.9%)	0 of 17 (0%)	0 of 17

Limitations and caveats (from the sponsor): There are limitations to the present analysis. Due to increasing use of SGLT2 inhibition for the clinical indication of HF and challenges posed by the COVID-19 pandemic, we were unable to meet the participant recruitment target for this trial. Therefore, our study was potentially underpowered to detect a difference between ertugliflozin and placebo groups in the primary outcome of FELi.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

David ZI Cherney, MD PhD principal investigator

University Health Network, Toronto General Hospital

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ertugliflozin in people with Type 2 Diabetes Mellitus and Heart Failure, run by University Health Network, Toronto at 3 sites in 2 countries.

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 10 inclusion and 17 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 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands, Canada. 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?

Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Fractional Excretion of Lithium (FELi) (time frame: Change in outcomes was measured acute (1 week minus baseline values) and chronic (12 weeks minus baseline values)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03416270.

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 6 May 2025.