An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of TA-7284 in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,299
- 试验地点
- 7
- 主要终点
- Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.
详细描述
This is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. The patients will receive either TA-7284-Low or TA-7284-High orally alone or in combination with oral anit-hyperglycaemic agent for 52 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
- 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
- •Men or women age ≥20 years old
- •Diagnosed with Type 2 diabetes mellitus at least 3 months before screening
- •HbA1c of ≥7.0% and ≤10.0% (monotherapy group)
- •HbA1c of ≥7.0% and ≤10.5% (combination therapy group)
排除标准
- •Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
- •Past or current history of severe diabetic complications
- •Fasting plasma glucose > 270 mg/dL before treatment start
- •History of hereditary glucose-galactose malabsorption or primary renal glucosuria
- •Patients requiring insulin therapy
研究组 & 干预措施
TA-7284-Low
干预措施: TA-7284-Low (Drug)
TA-7284-High
干预措施: TA-7284-High (Drug)
结局指标
主要结局
Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events
时间窗: 54 weeks
次要结局
- Change in HbA1c(Week 52)
- Change in Fasting Plasma Glucose(Week 52)
- Change in Body Weight(Week 52)
- Change in Blood Pressure(Week 52)