Effect of Ertugliflozin on Cardiac Function in Diabetes (ERTU-GLS)

August 10, 2023 updated by: Soo Lim

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospita;

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ertugliflozin
Ertugliflozin 5 mg in addition to their preexisting metformin and/or DPP4 inhibitor
Drug: Ertugliflozin
Ertugliflozin as add-on to Metformin and/or DPP4 inhibitors in patients with inadequately controlled type 2 diabetes
Other Names:
  • Steglatro
Placebo Comparator: Control group
Placebo in addition to their preexisting metformin and/or DPP4 inhibitor
Drug: Placebo
Placebo as add-on to Metformin and/or DPP4 inhibitors in patients with inadequately controlled type 2 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Longitudinal Strain (GLS)
Time Frame: Baseline, week 12, week 24
Change of GLS after 24 weeks' treatment
Baseline, week 12, week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
E/e' ratio
Time Frame: Baseline, week 12, week 24
Change of E/e' after 24 weeks' treatment
Baseline, week 12, week 24
Ejection fraction (EF)
Time Frame: Baseline, week 12, week 24
Change of EF after 24 weeks' treatment
Baseline, week 12, week 24
Left ventricle mass
Time Frame: Baseline, week 12, week 24
Change of LV mass after 24 weeks' treatment
Baseline, week 12, week 24
Glycated hemoglobin
Time Frame: Baseline, week 12, week 24
Change of HbA1c mass after 24 weeks' treatment
Baseline, week 12, week 24
Body weight
Time Frame: Baseline, week 12, week 24
Change of body weight mass after 24 weeks' treatment
Baseline, week 12, week 24
Body Fat Mass
Time Frame: Baseline, week 12, week 24
Change of body fat mass after 24 weeks' treatment
Baseline, week 12, week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soo Lim

Collaborators

MSD Korea Ltd.

Investigators

  • Principal Investigator: Soo Lim, MD, PhD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 23, 2018

First Posted (Actual)

October 24, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2018-498-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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