A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 983
- 试验地点
- 139
- 主要终点
- HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16
研究概览
简要总结
The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.
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
入排标准
- 年龄范围
- 18 Years 至 —（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 (high dose bid)
Patients receive Empagliflozin high dose split twice daily
干预措施: Placebo (Drug)
empagliflozin (high dose qd)
Patients receive Empagliflozin high dose once daily
干预措施: Placebo (Drug)
empagliflozin (high dose qd)
Patients receive Empagliflozin high dose once daily
干预措施: Empagliflozin (high dose qd) (Drug)
empagliflozin (high dose bid)
Patients receive Empagliflozin high dose split twice daily
干预措施: empagliflozin (high dose bid) (Drug)
empagliflozin (low dose qd)
Patients receive Empagliflozin low dose once daily
干预措施: empagliflozin (low dose qd) (Drug)
empagliflozin (low dose qd)
Patients receive Empagliflozin low dose once daily
干预措施: Placebo (Drug)
empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice daily
干预措施: Placebo (Drug)
empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice daily
干预措施: empagliflozin (low dose bid) (Drug)
Placebo
Patients receive placebo matching Empagliflozin
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16
时间窗: Baseline and 16 weeks
Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means.
次要结局
- Fasting Plasma Glucose (FPG) Change From Baseline at Week 16(Baseline and 16 weeks)