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Type2 DiabetesPhase 3ERTU-GLSNCT03717194

Effect of Ertugliflozin on Cardiac Function in Diabetes

A Phase 3 study testing Ertugliflozin in people with Type2 Diabetes and Heart Failure, run by Soo Lim at 1 site in South Korea.

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

The aim of this study is to investigate the beneficial role of ertugliflozin, a new SGLT2 inhibitor, in cardiac function via measuring GLS as well as other hemodynamic factors using echocardiogram in patients with T2D and HF, who are not controlled with oral antidiabetic medications including DPP4 inhibitors. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Type2 Diabetes, Heart Failure
What is being tested?
Ertugliflozin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
1 siteSouth Korea
Study dates
1 Jun 2019to 30 Apr 2023
Phase
Phase 3
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with T2D taking oral antidiabetic medications (metformin and/or DPP4 inhibitors) except SGLT2 inhibitors for at least 12 weeks without a dose adjustment before enrollment.
  • eGFR ≥ 45 mL/min/1.73 m2.
  • Stage B HF identified on the basis of either structural or functional markers.

Who cannot join

  • Type 1 diabetes mellitus
  • At the time of screening age <20 years
  • HbA1c <7% or HbA1c >9.5% at Screening
  • FPG >15 mmol/L (270 mg/dL) measured by the laboratory at Screening (Visit 1), and confirmed (>15 mmol/L [>270 mg/dL]) by a repeat test before randomization
  • Treated with insulin and/or GLP-1R agonist within 12 weeks preceding the Screening Visit.
  • Women of childbearing potential with no effective contraceptive method
Show all 15Show fewer
  • History of gastric surgery including history of gastric banding within 3 years before the Screening Visit
  • History of diabetic ketoacidosis or nonketotic hyperosmolar coma prior to the Screening Visit
  • Mean blood pressure after 3 separate measurements >180 mmHg in systolic blood pressure (SBP) or >95 mmHg in diastolic blood pressure (DBP)
  • Patients with current or prior symptoms of HF.
  • Patients with severe anemia, severe respiratory, hepatic, neurological, psychiatric disorders or active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult
  • Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limit of the normal laboratory range (ULN)
  • Total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome)
  • Use of systemic glucocorticoids (excluding topical or ophthalmic, application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit
  • Patient who has taken other investigational drugs or prohibited therapy for this study within 3 months

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Bundang Hospita;

    Seongnam-si, Gyeonggi-do, 13620

Other trials in South Korea

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, to Evaluate the Effect of Ertugliflozin on Cardiac Function in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control and Stage B Heart Failure

The aim of this study is to investigate the beneficial role of ertugliflozin, a new SGLT2 inhibitor, in cardiac function via measuring GLS as well as other hemodynamic factors using echocardiogram in patients with T2D and HF, who are not controlled with oral antidiabetic medications including DPP4 inhibitors.

Read the detailed description

This study is a phase 3, randomized, double-blind, active-competitor, parallel-group study that is anticipated to enroll 120 patients. Patients taking metformin and/or DPP4 inhibitors as per local label for ≥12 weeks without a dose adjustment before enrollment will be eligible for screening. All patients will have a screening period comprised of an up to 2-week screening phase prior to randomization. In order to qualify for randomization, patients must demonstrate compliance based upon pill count (80%) and discretion of the investigators during the Run-in phase.

Glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) will be masked to patients after randomization. To prevent partial unblinding, urinary glucose excretion (UGE) results will be masked to patients. Urine glucose, albumin, calcium, and creatinine will be measured separately on-site visits.

Being tested
Ertugliflozin, Placebo
Keywords
type 2 diabetes, heart failure, ertugliflozin, Global longitudinal strain (GLS)
Medical subject headings
Heart Failure, Diabetes Mellitus, Type 2

What participants receive

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

  • ErtugliflozinDrug

    Also called Steglatro

    Ertugliflozin as add-on to Metformin and/or DPP4 inhibitors in patients with inadequately controlled type 2 diabetes

  • PlaceboDrug

    Placebo as add-on to Metformin and/or DPP4 inhibitors in patients with inadequately controlled type 2 diabetes

Study groups in NCT03717194
Study groupRoleWhat they receive
ErtugliflozinExperimentalErtugliflozin 5 mg in addition to their preexisting metformin and/or DPP4 inhibitor
Receives: Drug: Ertugliflozin
Control groupPlacebo comparatorPlacebo in addition to their preexisting metformin and/or DPP4 inhibitor
Receives: Drug: Placebo

What is being measured

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

  1. Left Ventricular Global Longitudinal Strain (LVGLS)

    Change in LVGLS after 24 weeks of treatment

    Measured: Baseline, Week 24

Secondary outcomes (5)

  1. Left Ventricular Mass Index (LVMI)

    Change in LVMI after 24 weeks of treatment

    Measured: Baseline, Week 24

  2. Left Ventricular Ejection Fraction (LVEF)

    Change in LVEF after 24 weeks of treatment

    Measured: Baseline, Week 24

  3. E/e' Ratio

    Change in E/e' ratio after 24 weeks of treatment

    Measured: Baseline, Week 24

  4. Left Atrium Ventricular Index (LAVI)

    Change in LVVI after 24 weeks of treatment

    Measured: Baseline, Week 24

  5. Left Ventricular End-diastolic Volume (LVEDV)

    Change in LVEDV after 24 weeks of treatment

    Measured: Baseline, Week 24

Timeline

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

  1. First posted24 Oct 2018
  2. Study start1 Jun 2019
  3. Primary completion31 Dec 2022
  4. Study completion30 Apr 2023

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03717194
Sponsor's protocol ID
B-2018-498-002
Acronym
ERTU-GLS
Status last verified
Oct 2024
First submitted
22 Oct 2018
Last updated
20 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.

    PubMed 26378978

  • Neal B, Perkovic V, Matthews DR. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Nov 23;377(21):2099. doi: 10.1056/NEJMc1712572. No abstract available.

    PubMed 29166232

  • Krishnasamy R, Isbel NM, Hawley CM, Pascoe EM, Burrage M, Leano R, Haluska BA, Marwick TH, Stanton T. Left Ventricular Global Longitudinal Strain (GLS) Is a Superior Predictor of All-Cause and Cardiovascular Mortality When Compared to Ejection Fraction in Advanced Chronic Kidney Disease. PLoS One. 2015 May 15;10(5):e0127044. doi: 10.1371/journal.pone.0127044. eCollection 2015.

    PubMed 25978372

  • Hunt SA, Baker DW, Chin MH, Cinquegrani MP, Feldman AM, Francis GS, Ganiats TG, Goldstein S, Gregoratos G, Jessup ML, Noble RJ, Packer M, Silver MA, Stevenson LW, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Jacobs AK, Hiratzka LF, Russell RO, Smith SC; American College of Cardiology; American Heart Association. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult: executive summary. J Heart Lung Transplant. 2002 Feb;21(2):189-203. doi: 10.1016/s1053-2498(01)00776-8. No abstract available.

    PubMed 11834347

  • Kosmala W, Jellis CL, Marwick TH. Exercise limitation associated with asymptomatic left ventricular impairment: analogy with stage B heart failure. J Am Coll Cardiol. 2015 Jan 27;65(3):257-66. doi: 10.1016/j.jacc.2014.10.044. Epub 2014 Dec 19.

    PubMed 25533754

  • Kramer DG, Trikalinos TA, Kent DM, Antonopoulos GV, Konstam MA, Udelson JE. Quantitative evaluation of drug or device effects on ventricular remodeling as predictors of therapeutic effects on mortality in patients with heart failure and reduced ejection fraction: a meta-analytic approach. J Am Coll Cardiol. 2010 Jul 27;56(5):392-406. doi: 10.1016/j.jacc.2010.05.011.

    PubMed 20650361

  • Devereux RB, Alonso DR, Lutas EM, Gottlieb GJ, Campo E, Sachs I, Reichek N. Echocardiographic assessment of left ventricular hypertrophy: comparison to necropsy findings. Am J Cardiol. 1986 Feb 15;57(6):450-8. doi: 10.1016/0002-9149(86)90771-x.

    PubMed 2936235

  • Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. doi: 10.1016/j.echo.2005.10.005. No abstract available.

    PubMed 16376782

  • Nagueh SF, Appleton CP, Gillebert TC, Marino PN, Oh JK, Smiseth OA, Waggoner AD, Flachskampf FA, Pellikka PA, Evangelista A. Recommendations for the evaluation of left ventricular diastolic function by echocardiography. J Am Soc Echocardiogr. 2009 Feb;22(2):107-33. doi: 10.1016/j.echo.2008.11.023. No abstract available.

    PubMed 19187853

  • Reisner SA, Lysyansky P, Agmon Y, Mutlak D, Lessick J, Friedman Z. Global longitudinal strain: a novel index of left ventricular systolic function. J Am Soc Echocardiogr. 2004 Jun;17(6):630-3. doi: 10.1016/j.echo.2004.02.011.

    PubMed 15163933

  • Lima MSM, Villarraga HR, Abduch MCD, Lima MF, Cruz CBBV, Sbano JCN, Voos MC, Mathias W Junior, Tsutsui JM. Global Longitudinal Strain or Left Ventricular Twist and Torsion? Which Correlates Best with Ejection Fraction? Arq Bras Cardiol. 2017 Jul;109(1):23-29. doi: 10.5935/abc.20170085. Epub 2017 Jun 29.

    PubMed 28678927

  • Medvedofsky D, Kebed K, Laffin L, Stone J, Addetia K, Lang RM, Mor-Avi V. Reproducibility and experience dependence of echocardiographic indices of left ventricular function: Side-by-side comparison of global longitudinal strain and ejection fraction. Echocardiography. 2017 Mar;34(3):365-370. doi: 10.1111/echo.13446. Epub 2017 Feb 9.

    PubMed 28185312

  • Lim S, Bae JH, Oh H, Hwang IC, Yoon YE, Cho GY. Effect of ertugliflozin on left ventricular function in type 2 diabetes and pre-heart failure: the Ertu-GLS randomized clinical trial. Cardiovasc Diabetol. 2024 Oct 22;23(1):373. doi: 10.1186/s12933-024-02463-0.

    PubMed 39438942

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ertugliflozin in people with Type2 Diabetes and Heart Failure, run by Soo Lim at 1 site in South Korea.

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 3 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 20 Nov 2024. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 20 Nov 2024). 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?

Left Ventricular Global Longitudinal Strain (LVGLS) (time frame: Baseline, Week 24). 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 NCT03717194, which also lists 13 linked publications.

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 20 Nov 2024.

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