NCT01159249已完成3 期
A Multicenter, Open Label, Long-Term Safety Study of 52 Weeks Treatment With Vildagliptin 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
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Measure AEs, vital signs, laboratory evaluations
研究概览
简要总结
This study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or α-GI, or glinides monotherapy
- •Age in the 20 years or over inclusive
- •HbA1c in the range of ≥ 6.5 to ≤ 10%
排除标准
- •Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
- •Significant heart diseases
- •Significant diabetic complications
研究组 & 干预措施
Open Met add-on vildagliptin
Other
干预措施: Vildagliptin (Drug)
Open TZD add-on vildagliptin
Other
干预措施: Vildagliptin (Drug)
Open α-GI add-on vildagliptin
Other
干预措施: Vildagliptin (Drug)
Glinides add-on vildagliptin
Other
干预措施: Vildagliptin (Drug)
结局指标
主要结局
Measure AEs, vital signs, laboratory evaluations
时间窗: 52 weeks
次要结局
- HBA1c(52 weeks)
- Fasting Plasma Glucose(52 weeks)
- Fasting Insulin(52 weeks)
- Fasting C-peptide(52 weeks)
- HOMA-B(52 weeks)
研究者
研究点 (1)
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