NCT01233622已完成3 期
A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 317
- 试验地点
- 6
- 主要终点
- HbA1c Reduction
研究概览
简要总结
This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).
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
- 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
Vildagliptin (metformin + glimepiride)
Experimental
干预措施: Vildagliptin (Drug)
Placebo (metformin + glimepiride)
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c Reduction
时间窗: 24 weeks
次要结局
- Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs)(24 weeks)
- Responder Rate(24 weeks)
- FPG reduction(24 weeks)
研究者
研究点 (6)
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