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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717194
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
MSD Korea Ltd.
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Heart Failure Drug: Ertugliflozin Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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 Name: 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




Primary Outcome Measures :
  1. Global Longitudinal Strain (GLS) [ Time Frame: Baseline, week 12, week 24 ]
    Change of GLS after 24 weeks' treatment


Secondary Outcome Measures :
  1. E/e' ratio [ Time Frame: Baseline, week 12, week 24 ]
    Change of E/e' after 24 weeks' treatment

  2. Ejection fraction (EF) [ Time Frame: Baseline, week 12, week 24 ]
    Change of EF after 24 weeks' treatment

  3. Left ventricle mass [ Time Frame: Baseline, week 12, week 24 ]
    Change of LV mass after 24 weeks' treatment

  4. Glycated hemoglobin [ Time Frame: Baseline, week 12, week 24 ]
    Change of HbA1c mass after 24 weeks' treatment

  5. Body weight [ Time Frame: Baseline, week 12, week 24 ]
    Change of body weight mass after 24 weeks' treatment

  6. Body Fat Mass [ Time Frame: Baseline, week 12, week 24 ]
    Change of body fat mass after 24 weeks' treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03717194


Contacts
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Contact: Jie-Eun Lee, MD +82-31-787-7815 jeleemd@gmail.com
Contact: Soo Lim, MD, PhD +82-31-787-7035 limsoo@snu.ac.kr

Locations
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Korea, Republic of
Seoul National University Bundang Hospita; Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Soo Lim    82317877035 ext 82317877035    limsoo@snu.ac.kr   
Sponsors and Collaborators
Soo Lim
MSD Korea Ltd.
Investigators
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Principal Investigator: Soo Lim, MD, PhD Seoul National University Bundang Hospital
Publications:

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Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03717194    
Other Study ID Numbers: B-2018-498-002
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Soo Lim, Seoul National University Bundang Hospital:
type 2 diabetes
heart failure
ertugliflozin
Global longitudinal strain (GLS)
Additional relevant MeSH terms:
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Heart Failure
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-hydroxymethyl-6,8-dioxabicyclo(3.2.1)octane-2,3,4-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs