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

Soo Lim

Status and phase

Completed

Phase 3

Conditions

Type2 Diabetes

Heart Failure

Treatments

Drug: Placebo

Drug: Ertugliflozin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03717194

B-2018-498-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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