JPRN-jRCT1080222358未知4 期
A 12-week, multi-center, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of Equa (vildagliptin) 50 mg bid as an add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus
ovartis Pharma K.K.0 个研究点目标入组 152 人开始时间: 2014年1月7日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 152
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •*Confirmed diagnosis of T2DM by standard criteria.
- •*HbA1c >= 7.0 to <= 10% at Visit 1.
- •*Age: >= 20 to < 75 years old at Visit 1.
- •*BMI >= 20 to <= 35 kg/m2 at Visit 1.
排除标准
- •*FPG >= 270 mg/dL (>= 15 mmol/L) at Visit 1.
- •*Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
- •*Significant heart diseases
- •*Hepatic disorder
- •Other protocol-defined inclusion/exclusion criteria may apply.
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