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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Left Ventricular Global Longitudinal Strain (LVGLS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Ertugliflozin
Ertugliflozin 5 mg in addition to their preexisting metformin and/or DPP4 inhibitor
干预措施: Ertugliflozin (Drug)
Control group
Placebo in addition to their preexisting metformin and/or DPP4 inhibitor
干预措施: Placebo (Drug)
结局指标
主要结局
Left Ventricular Global Longitudinal Strain (LVGLS)
时间窗: Baseline, Week 24
Change in LVGLS after 24 weeks of treatment
次要结局
- 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)
研究者
Soo Lim
Professor
Seoul National University Bundang Hospital