Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 515
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c after 24 weeks
研究概览
简要总结
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Blood glucose criteria must be met
- •Previously treated with a sulfonylurea for at least 3 months
- •Body mass index (BMI) in the range 22-45
排除标准
- •Type 1 diabetes
- •Pregnancy or lactation
- •Evidence of serious cardiovascular complications
- •Evidence of serious diabetic complications
- •Laboratory value abnormalities as defined by the protocol
- •Known sensitivity to glimepiride
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
LAF237 50 mg bid + glimepiride 4 mg qd
LAF237 50 mg bid + glimepiride 4 mg qd
干预措施: vildagliptin (Drug)
LAF237 50 mg qd + glimepiride 4 mg qd
LAF237 50 mg qd + glimepiride 4 mg qd
干预措施: vildagliptin (Drug)
LAF237 50 mg qd + glimepiride 4 mg qd
LAF237 50 mg qd + glimepiride 4 mg qd
干预措施: Glimepiride (Drug)
LAF237 50 mg bid + glimepiride 4 mg qd
LAF237 50 mg bid + glimepiride 4 mg qd
干预措施: Glimepiride (Drug)
LAF237 placebo + glimepiride 4 mg qd
LAF237 placebo + glimepiride 4 mg qd
干预措施: Glimepiride (Drug)
LAF237 placebo + glimepiride 4 mg qd
LAF237 placebo + glimepiride 4 mg qd
干预措施: LAF237 placebo (Drug)
结局指标
主要结局
Change from baseline in HbA1c after 24 weeks
次要结局
- Patients with reduction in HbA1c >/=to 0.7% after 24 weeks
- Change from baseline in fasting plasma glucose at 24 weeks
- Patients with endpoint HbA1c <7% after 24 weeks
- Adverse event profile after 24 weeks of treatment
- Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c