NCT02227849已完成4 期
An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Canagliflozin (TA-7284) as add-on to GLP-1 Analogue in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 4
- 主要终点
- Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.
详细描述
This is an open-label study to evaluate the long-term safety and efficacy of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with GLP-1 analogue on diet and exercise and have inadequate glycemic control. The patients will receive TA-7284 100mg orally for 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who has been receiving a stable dose and regimen of GLP-1 analogue over 12 weeks before administration of investigational dug
- •Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
- •Patients with HbA1c of ≥7.0% and <10.5%
- •Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug
排除标准
- •Patients with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (Cushing's syndrome, acromegaly, etc.)
- •Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)
- •Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
- •Patients with systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg
- •Patients with serious renal or hepatic disease
- •Patients with eGFR of <45 mL/min/1.73 m2
- •Patients who are the excessive alcohol addicts
- •Patients requiring insulin therapy
- •Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception
研究组 & 干预措施
Canagliflozin (TA-7284) ＋GLP-1 analogue
Experimental
干预措施: Canagliflozin (TA-7284) (Drug)
Canagliflozin (TA-7284) ＋GLP-1 analogue
Experimental
干预措施: GLP-1 analogue (Drug)
结局指标
主要结局
Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
时间窗: 52 Weeks
次要结局
- Change in Percentage of HbA1c(Baseline, 52 Weeks)
- Change in Fasting Plasma Glucose(Baseline, 52 Weeks)
- Percentage Change in Body Weight(Baseline, 52 Weeks)
- Change in Blood Pressure(Baseline, 52 Weeks)
研究者
研究点 (4)
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