NCT02589639已完成4 期
A 52-week Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Empagliflozin Once Daily, as an add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
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
- 269
- 试验地点
- 48
- 主要终点
- Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment.
研究概览
简要总结
This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control
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 74 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
empagliflozin 10 mg
Experimental
干预措施: Placebo (Drug)
empagliflozin 25 mg
Experimental
干预措施: Empagliflozin (Drug)
empagliflozin 10 mg
Experimental
干预措施: Empagliflozin (Drug)
empagliflozin 25 mg
Experimental
干预措施: Placebo (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment.
时间窗: Baseline and 16 weeks
The primary endpoint was the change from baseline in HbA1c after 16 weeks of treatment. The term "baseline" refers to the last observation prior to the administration of any randomised study drug. Means presented are the adjusted means.
次要结局
- Percentage of Patients With Investigator Defined Drug-Related Adverse Events (AEs)(From 1st intake of study drug to last intake of study drug + 7 days; up to 53 weeks)
研究者
研究点 (48)
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