A Clinical Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes

Novartis Pharmaceuticals2 个研究点分布在 1 个国家目标入组 639 人开始时间: 2004年4月最近更新: 2012年5月2日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis Pharmaceuticals
入组人数: 639
试验地点: 2
主要终点: Change from baseline in HbA1c at 24 weeks

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

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

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

•Body mass index (BMI) in the range 22-45
•Blood glucose criteria must be met
•Not currently on drug therapy for type 2 diabetes

排除标准

•Type 1 diabetes
•Evidence of serious diabetic complications
•Evidence of serious cardiovascular conditions
•Laboratory value abnormalities as defined by the protocol
•Other protocol-defined exclusion criteria may apply

结局指标

主要结局

Change from baseline in HbA1c at 24 weeks

次要结局

Change from baseline in fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c <7% after 24 weeks
Patients with reduction in HbA1c>/=to 0.7% after 24 weeks
Change from baseline in body weight at 24 weeks
Change from baseline in fasting lipids at 24 weeks

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

研究点 (2)

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