An Open-label, Randomized and Crossover Study to Assess the Effect of Co-administration of Vildagliptin and Voglibose on the Steady-state Pharmacokinetics / Pharmacodynamics in Japanese Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of vildagliptin
研究概览
简要总结
This study will evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics of vildagliptin in Japanese patients with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic patients with inadequately controlled on diet therapy and exercise therapy (HbA1c in the range 6.5 to 10.0% inclusive by NGSP)
排除标准
- •Fasting plasma glucose ≥ 270 mg/dL A history of Type 1 diabetes or secondary forms of diabetes Treatment of anti-diabetic agents including GLP-1 analogues within 8 weeks or insulin within 6 months prior to screening Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Treatment Sequence 1
干预措施: Vildagliptin (LAF237) (Drug)
Treatment Sequence 1
干预措施: Voglibose (Drug)
Treatment Sequence 1
干预措施: Vildagliptin and Voglibose (Drug)
Treatment Sequence 2
干预措施: Vildagliptin (LAF237) (Drug)
Treatment Sequence 6
干预措施: Voglibose (Drug)
Treatment Sequence 6
干预措施: Vildagliptin and Voglibose (Drug)
Treatment Sequence 2
干预措施: Voglibose (Drug)
Treatment Sequence 2
干预措施: Vildagliptin and Voglibose (Drug)
Treatment Sequence 3
干预措施: Vildagliptin (LAF237) (Drug)
Treatment Sequence 3
干预措施: Voglibose (Drug)
Treatment Sequence 3
干预措施: Vildagliptin and Voglibose (Drug)
Treatment Sequence 4
干预措施: Vildagliptin (LAF237) (Drug)
Treatment Sequence 4
干预措施: Voglibose (Drug)
Treatment Sequence 4
干预措施: Vildagliptin and Voglibose (Drug)
Treatment Sequence 5
干预措施: Vildagliptin (LAF237) (Drug)
Treatment Sequence 5
干预措施: Voglibose (Drug)
Treatment Sequence 5
干预措施: Vildagliptin and Voglibose (Drug)
Treatment Sequence 6
干预措施: Vildagliptin (LAF237) (Drug)
结局指标
主要结局
Pharmacokinetics of vildagliptin
时间窗: Up to 12 hours post-dose
次要结局
- Pharmacodynamic parameters (dipeptidyl peptidase IV (DPP-4) activity, glucagon-like peptide-1(GLP-1), glucose, insulin, glucagon)(Up to 4 hours or 12 hours post-dose)