A 28-day Randomised, Placebo-controlled, Double-blind Parallel Group Phase IIa Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once Daily Oral Doses of 2.5 mg, 10 mg, and 25 mg Empagliflozin as Adjunctive to Insulin in Patients With Type 1 Diabetes Mellitus (EASE-2)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change From Baseline in 24 h UGE (g/24 h) After Seven Days of Treatment With Empagliflozin 2.5 mg, 10 mg, or 25 mg, or Placebo
研究概览
简要总结
Placebo-controlled, double blind (triple-dummy technique), randomised parallel design comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with T1DM as adjunctive therapy to insulin over 28 days. Patients will undergo a 14-day open-label placebo run-in period before randomisation. Background insulin therapy will be kept stable during the first 7 days of the treatment period and will be freely adjusted thereafter.
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 65 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 low
Empagliflozin low once daily
干预措施: Empagliflozin low (Drug)
Empagliflozin low
Empagliflozin low once daily
干预措施: Empagliflozin medium placebo (Drug)
Empagliflozin low
Empagliflozin low once daily
干预措施: Empagliflozin high placebo (Drug)
Empagliflozin medium
Empagliflozin medium once daily
干预措施: Empagliflozin low placebo (Drug)
Empagliflozin medium
Empagliflozin medium once daily
干预措施: Empagliflozin high placebo (Drug)
Empagliflozin medium
Empagliflozin medium once daily
干预措施: Empagliflozin medium (Drug)
Empagliflozin high
Empagliflozin high once daily
干预措施: Empagliflozin medium placebo (Drug)
Empagliflozin high
Empagliflozin high once daily
干预措施: Empagliflozin low placebo (Drug)
Empagliflozin high
Empagliflozin high once daily
干预措施: Empagliflozin high (Drug)
Placebo
Placebo once daily
干预措施: Empagliflozin low placebo (Drug)
Placebo
Placebo once daily
干预措施: Empagliflozin high placebo (Drug)
Placebo
Placebo once daily
干预措施: Empagliflozin medium placebo (Drug)
结局指标
主要结局
Change From Baseline in 24 h UGE (g/24 h) After Seven Days of Treatment With Empagliflozin 2.5 mg, 10 mg, or 25 mg, or Placebo
时间窗: baseline (Day -1) and 7 days after first drug administration (Day 7)
Change of urinary glucose excretion (UGE) (g/24 h) from baseline (refers to the last measurement prior to the first intake of any randomised trial medication) after seven days of treatment with empagliflozin 2.5 mg, 10 mg, or 25 mg, or placebo. The treatment effect was estimated on the basis of the least square mean treatment difference at Day 7 extracted from the primary analysis model. The primary endpoint is exploratory.
次要结局
未报告次要终点