A Double-Blind, Placebo-Controlled, Randomized, Parallel-Groups Study to Investigate the Effects of JNJ-28431754 (Canagliflozin) on Plasma Volume and Renal Function in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Change in plasma volume (PV)
研究概览
简要总结
The purpose of the study is to evaluate the effects of canagliflozin on plasma volume and renal parameters in patients with Type 2 Diabetes Mellitus who are currently taking metformin and being treated for high blood pressure.
详细描述
This is a double-blind (neither the patient or study staff will know the identity of the treatment assigned) in patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic (blood sugar) control on metformin monotherapy (metformin taken alone for control of T2DM) and who are currently being treated for hypertension (high blood pressure) with agents called angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs). In the study, patients will be randomized (assigned by chance) to receive treatment with canagliflozin or a placebo (a treatment identical in appearance to canagliflozin but does not contain active drug) for 12 weeks. During the 12-week treatment period, patients will also take metformin at a dose of at least 1500 mg/day in addition to their prescribed ACEI or ARB for hypertension. Patients will participate in the study for up to approximately 22 weeks.
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must have a diagnosis of T2DM with inadequate glycemic control (ie, HbA1c of >=7.0% and <=9.0% at Screening) on metformin monotherapy and be receiving therapy with an antihypertensive agent (an ACEI or ARB) for at least 4 weeks prior to Screening
排除标准
- •History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy; or a severe hypoglycemic episode within 6 months before screening
研究组 & 干预措施
Canagliflozin
干预措施: Canagliflozin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in plasma volume (PV)
时间窗: Baseline to Week 12 of the double-blind treatment period
Baseline is defined as up to 3 days predose (Week -1)
Change in chemistry laboratory analytes
时间窗: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Number of hypoglycemic events reported
时间窗: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Change from baseline in urinalysis laboratory analytes
时间窗: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Number of patients who experience at least 1 occurrence of a treatment-related adverse event
时间窗: Day 1 to Day 85
Treatment-related adverse events are adverse events with onset during the treatment phase.
Change in blood pressure measurements
时间窗: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Number of patients with physical examination findings reported as adverse events
时间窗: Baseline up to Week 12
Baseline is defined as up to 3 days predose (Week -1)
Change in electrocardiogram (ECG) parameters
时间窗: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Change in hematology laboratory analytes
时间窗: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Change from baseline in pulse rate (beats/minute)
时间窗: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
次要结局
- Change in 24-hour fractional and total excretion of uric acid(Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase)
- Change in 24-hour urine volume(Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase)
- Change in body weight(Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase)
- Change in urine pH(Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase)
- Change in PV(Baseline to Week 1 of the double-blind treatment period)
- Change in percent Hemoglobin A1c (HbA1c)(Baseline to Week 12)