A Study to Evaluate the Effect of JNJ-28431754 (Canagliflozin) on Post-Meal Glucose in Patients With Type 2 Diabetes Mellitus
A Double-Blind, Placebo-Controlled, Randomized, Crossover, Multicenter Study to Evaluate the Effect of JNJ-28431754 (Canagliflozin) on Post-Meal Glucose in Subjects With Type 2 Diabetes Mellitus
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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California
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Chula Vista、California、美国
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Florida
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Miramar、Florida、美国
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Ohio
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Cincinnati、Ohio、美国
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Texas
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Dallas、Texas、美国
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San Antonio、Texas、美国
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with T2DM with inadequate glycemic control (based upon fasting glucose measurements >=130 mg/dL and <=250 mg/dL) on metformin monotherapy or on metformin in dual combination with other glucose lowering agents (sulphonylurea [SU] or a meglitinide or a dipeptidyl peptidase-4 [DPP-4] inhibitor) are eligible for enrollment in the study.
Exclusion Criteria:
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- history of a severe hypoglycemic episode within 6 months before screening
- Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements >=250 mg/dL (13.88 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
- History of or current illness considered to be clinically significant by the investigator
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：001
Placebo Treatment A: Form=capsule route=oral administration.
Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.
|
Treatment A: Form=capsule, route=oral administration.
Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.
|
|
实验性的：002
Canagliflozin 300mg/Placebo Treatment B: Type=1 unit=mg number=300 form=capsule route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods. Form=capsule route=oral administration. Capsule is taken once on Day 2 in 1 of 4 treatment periods. |
Treatment B: Type=1, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods. Form=capsule, route=oral administration. Capsule is taken once on Day 2 in 1 of 4 treatment periods. |
|
实验性的：003
Canagliflozin 300mg Treatment C: Type=1 unit=mg number=300 form=capsule route=oral use.
Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.
|
Treatment C: Type=1, unit=mg, number=300, form=capsule, route=oral use.
Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.
|
|
实验性的：004
Canagliflozin 300mg/Canagliflozin 150mg Treatment D: Type=1 unit=mg number=300 form=capsule route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods. Type=1 unit=mg number=150 form=capsule route=oral use. Capsule is taken once on Day 2 in 1 of 4 treatment periods. |
Treatment D: Type=1, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods. Type=1, unit=mg, number=150, form=capsule, route=oral use. Capsule is taken once on Day 2 in 1 of 4 treatment periods. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Plasma concentrations of glucose
大体时间：Up to Day 44
|
Up to Day 44
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Rate of insulin secretion
大体时间：Up to Day 44
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Up to Day 44
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Urinary glucose excretion (UGE)
大体时间：Up to Day 44
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Up to Day 44
|
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Renal threshold of glucose excretion (RTG)
大体时间：Up to Day 44
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Up to Day 44
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Adverse events
大体时间：Up to approximately Day 44
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Up to approximately Day 44
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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