An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Canagliflozin (TA-7284) as add-on to Insulin in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 7
- 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
This extension study was designed to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The extension study was an extension to double-blind study of 16 weeks (TA-7284-11)
详细描述
This is an open-label extension study to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with insulin in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will enroll from the double-blind study of 16 weeks and receive TA-7284 100mg orally for 36 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 should complete the week 16 assessments in the double-blind study (TA-7284-11)
排除标准
- •Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
- •Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)
- •Patients with serious renal or hepatic disease
- •Patients who are the excessive alcohol addicts
- •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) ＋insulin
干预措施: Canagliflozin (TA-7284) (Drug)
Canagliflozin (TA-7284) ＋insulin
干预措施: Insulin (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: Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
次要结局
- Change in Percentage of HbA1c(Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks)
- Change in Fasting Plasma Glucose(Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks)
- Percentage Change in Body Weight(Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks)