NCT02220920已完成4 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin (TA-7284) as add-on to Insulin 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
- 146
- 试验地点
- 7
- 主要终点
- Change in HbA1c From Baseline
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.
详细描述
This is a randomized, 2-arm, parallel group, double blind study to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with insulin therapy on diet and exercise and have inadequate glycemic control. The patients will receive either TA-7284 100mg or Placebo orally for 16 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
- Triple (Participant, Care Provider, Outcomes Assessor)
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 insulin 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 ≥7.5% 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 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
Experimental
干预措施: Canagliflozin (TA-7284) (Drug)
Canagliflozin (TA-7284) ＋insulin
Experimental
干预措施: Insulin (Drug)
Placebo＋insulin
Placebo Comparator
干预措施: Placebo (Drug)
Placebo＋insulin
Placebo Comparator
干预措施: Insulin (Drug)
结局指标
主要结局
Change in HbA1c From Baseline
时间窗: baseline and Week 16
次要结局
- Change in Blood Pressure(baseline and Week 16)
- Change in Fasting Plasma Glucose(baseline and Week 16)
- Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased"(Week 16)
- Percent Change in Body Weight(baseline and Week 16)
研究者
研究点 (7)
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