NCT03190798撤回4 期
A Randomized, Double-Blind, Placebo-Controlled, Single-Center, Mechanistic Study to Evaluate the Effects of Canagliflozin on Intravascular Volume and Hemodynamics in Subjects With Type 2 Diabetes Mellitus and Heart Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Pulmonary capillary wedge pressure (PCWP)
研究概览
简要总结
RESEARCH HYPOTHESIS
- In subjects with T2DM and HF, effect of canagliflozin will be superior to placebo for the change from baseline in PCWP after a single dose (6 hours post-dose) and after 4 weeks.
- Treatment with canagliflozin will be well tolerated over 4 weeks.
详细描述
This is a randomized, double-blind, placebo-controlled, parallel-group, single-center study (Figure 1). Thirty subjects will be randomized in a 3:2 randomization ratio to canagliflozin 300 mg once daily (QD) or placebo. The study will include a 3-week pretreatment screening phase and a 4-week double-blind treatment phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •on stable doses (more than 3 months) of antihyperglycemic agents (except for an SGLT2 inhibitor and insulin)
- •have an A1c ≥7% and ≤11%
- •Estimated glomerular filtration rate (eGFR) must be ≥45 ml/min•1.73 m2
- •have an NT-proBNP ≥500 pg/mL
- •be on a stable dose of guideline-directed HF medication (i.e., angiotensin converting enzyme [ACE] inhibitor, angiotensin II receptor blocker [ARB], or angiotensin receptor neprilysin inhibitor [ARNI], β-blocker, diuretics, and/or mineralcorticoid receptor antagonist) for at least 4 weeks
- •be on stable antihypertensive therapy for at least 2 months
排除标准
- •repeated fasting plasma glucose (FPG) or fasting self-monitored blood glucose measurements ≥240 mg/dL or both
- •during the pretreatment phase, NYHA Class IV HF status, uncontrolled hypertension as defined as systolic blood pressure (SBP) >160 or diastolic blood pressure (DBP) >100 mmHg
- •liver disease (ALT or AST >3 x ULN)
- •anemia Hb<10
- •anticipated cardiac surgery or coronary intervention within the next 3 months
- •severe unremediated valvular heart disease
- •major CV event (e.g., MI, cerebrovascular accident) within 3 months prior to screening visit
- •hospitalization for HF within 2 months prior to screening visit
- •documented atrial fibrillation
- •history of atraumatic amputation within past 12 months of screening or critical ischemia of the lower extremity within 6 months of screening
- •an active skin ulcer, osteomyelitis, or gangrene
- •have an allergy to iodocyanine green and inulin
研究组 & 干预措施
Canagliflozin Group
Active Comparator
Assuming a 25% dropout rate, 16 individuals in the canagliflozin group
干预措施: Canagliflozin 300mg (Drug)
Placebo Group
Placebo Comparator
Assuming a 25% dropout rate, 11 individuals in the placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Pulmonary capillary wedge pressure (PCWP)
时间窗: 6 hours
The primary efficacy endpoint will be change in PCWP from baseline to end of acute administration monitoring period (6 hours).
次要结局
- Change in Pulmonary capillary wedge pressure (PCWP)(4 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and SitagliptinDiabetes Mellitus, Type 2NCT02025907Janssen Research & Development, LLC218
已完成
3 期
A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT03170518Janssen Research & Development, LLC171
已完成
3 期
CANVAS - CANagliflozin cardioVascular Assessment StudyCardiovascular DiseasesRisk FactorsDiabetes Mellitus, Type 2NCT01032629Janssen Research & Development, LLC4,330
已完成
2 期
A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)Diabetes Mellitus, Type 1NCT02139943Janssen Research & Development, LLC352
已完成
4 期
A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes MellitusAlbuminuriaDiabetes Mellitus, Type 2NCT01989754Janssen Research & Development, LLC5,813