A Randomized, Double-blind, Placebo-controlled, Parallel Groups Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Three BI 187004 Doses Given Once Daily as Mono-therapy and of the Highest BI 187004 Dose Given Once Daily as Add on Treatment to Metformin Over 28 Days in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 3
- 主要终点
- The percentage of patients with drug- related adverse events
研究概览
简要总结
Assess the safety and tolerability of once daily oral doses of BI 187004 in patients with type 2 diabetes mellitus without oral antidiabetic treatment and in patients on a stable metformin background treatment over 28 days. Assess the effect on fasting plasma glucose after 28 days of treatment and to investigate the pharmacokinetics and pharmacodynamics of BI 187004.
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 80 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
BI 187004 low dose mono QD
patient to receive one tablet containing low dose of BI 187004 or matching placebo
干预措施: Placebo (Drug)
BI 187004 low dose mono QD
patient to receive one tablet containing low dose of BI 187004 or matching placebo
干预措施: BI 187004 (Drug)
BI 187004 medium dose mono QD
patient to receive one tablet containing medium dose mg of BI 187004 or matching placebo
干预措施: Placebo (Drug)
BI 187004 medium dose mono QD
patient to receive one tablet containing medium dose mg of BI 187004 or matching placebo
干预措施: BI 187004 (Drug)
BI 187004 high dose mono QD
patient to receive one tablet containing high dose of BI 187004 or matching placebo
干预措施: Placebo (Drug)
BI 187004 high dose mono QD
patient to receive one tablet containing high dose of BI 187004 or matching placebo
干预措施: BI 187004 (Drug)
BI 187004 high dose QD add on
patient to receive one tablet containing high dose of BI 187004 or matching placebo add on to metformin background dose
干预措施: Placebo (Drug)
BI 187004 high dose QD add on
patient to receive one tablet containing high dose of BI 187004 or matching placebo add on to metformin background dose
干预措施: BI 187004 (Drug)
结局指标
主要结局
The percentage of patients with drug- related adverse events
时间窗: 6 weeks
次要结局
- Change from baseline in fasting plasma glucose (FPG) after 28 days of treatment(4 weeks)