A Randomized, Double Blind Placebo Controlled 2-Arm Parallel Group, Multicenter Study With A 16-Week Treatment Assessing The Efficacy And Safety, And 52-Week Long Term Safety Including 36-Week Open Label Extension Of Tofogliflozin With Insulin Treatment In Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 211
- 试验地点
- 30
- 主要终点
- Change in HbA1c from baseline
研究概览
简要总结
Primary Objectives:
To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over a period of 16 weeks in patients with type 2 diabetes mellitus.
To assess the safety of tofogliflozin in combination with insulin treatment throughout 52 weeks.
Secondary Objectives:
To assess the effects of tofogliflozin in comparison to placebo on:
- Body weight
- Fasting plasma glucose (FPG)
- Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of tofogliflozin.
详细描述
The total study duration from screening for a patient can be approximately up to 1 year, including a screening period of 2 weeks, double-blinded placebo controlled treatment period of 16 weeks, an open-labeled extension period of 36 weeks, and a follow-up period of 3 days.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
placebo
Placebo administered once daily for 16 weeks. After 16-weeks, Tofogliflozin administered once daily for 36 weeks. Insulin administered as base treatment.
干预措施: insulin (Drug)
tofogliflozin
Tofogliflozin administered once daily for 52 weeks. Insulin administered as base treatment.
干预措施: TOFOGLIFLOZIN CSG452 (Drug)
tofogliflozin
Tofogliflozin administered once daily for 52 weeks. Insulin administered as base treatment.
干预措施: insulin (Drug)
placebo
Placebo administered once daily for 16 weeks. After 16-weeks, Tofogliflozin administered once daily for 36 weeks. Insulin administered as base treatment.
干预措施: TOFOGLIFLOZIN CSG452 (Drug)
placebo
Placebo administered once daily for 16 weeks. After 16-weeks, Tofogliflozin administered once daily for 36 weeks. Insulin administered as base treatment.
干预措施: placebo (Drug)
结局指标
主要结局
Change in HbA1c from baseline
时间窗: 16 weeks after first intake of investigational product
次要结局
- Change of Body Weight (BW) from baseline(16 weeks after first intake of investigational product)
- Change of FPG from baseline(16 weeks after first intake of investigational product)
- Change of PPG from baseline(16 weeks after first intake of investigational product)
- Number of subjects with adverse events(Up to 52 weeks from the first intake of investigational medicinal product)