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
Overview
- Phase
- Phase 3
- Intervention
- Ertugliflozin
- Conditions
- Type2 Diabetes
- Sponsor
- Soo Lim
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Left Ventricular Global Longitudinal Strain (LVGLS)
- Status
- Completed
- Last Updated
- last year
Overview
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.
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.
Investigators
Soo Lim
Professor
Seoul National University Bundang Hospital
Eligibility 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 m
- •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.
Arms & Interventions
Ertugliflozin
Ertugliflozin 5 mg in addition to their preexisting metformin and/or DPP4 inhibitor
Intervention: Ertugliflozin
Control group
Placebo in addition to their preexisting metformin and/or DPP4 inhibitor
Intervention: Placebo
Outcomes
Primary Outcomes
Left Ventricular Global Longitudinal Strain (LVGLS)
Time Frame: Baseline, Week 24
Change in LVGLS after 24 weeks of treatment
Secondary Outcomes
- Left Ventricular Mass Index (LVMI)(Baseline, Week 24)
- Left Ventricular Ejection Fraction (LVEF)(Baseline, Week 24)
- E/e' Ratio(Baseline, Week 24)
- Left Atrium Ventricular Index (LAVI)(Baseline, Week 24)
- Left Ventricular End-diastolic Volume (LVEDV)(Baseline, Week 24)