Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes

Novartis Pharmaceuticals1 个研究点分布在 1 个国家目标入组 594 人开始时间: 2005年4月1日最近更新: 2012年5月7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: 594
试验地点: 1
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

This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to acarbose 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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Not currently on drug therapy for type 2 diabetes
•Body mass index (BMI) in the range 20-40
•Blood glucose criteria must be met

排除标准

•Pregnancy or lactation
•Type 1 diabetes
•Evidence of significant 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 HbA1c at 24 weeks for subset of Chinese patients
Overall adverse event profile after 24 weeks of treatment
Gastrointestinal side effect profiles after 24 weeks of treatment
Change from baseline in fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c <7% after 24 weeks

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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