A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With Vildagliptin (50mg qd, 50mg Bid, 100mg qd) to Placebo in Patients With Type 2 Diabetes

Novartis1 个研究点分布在 1 个国家目标入组 236 人开始时间: 2006年6月1日最近更新: 2007年5月9日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 236
试验地点: 1
主要终点: Change from baseline on HbA1c at 12 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. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is to evaluate the effect of vildagliptin 50mg qd, 50mg bid or 100mg qd compared to placebo in patients with type 2 diabetes.

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: 20 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of type 2 diabetes
•Patients who have been placed on dietary therapy/exercise therapy without achievement of glycemic control
•Outpatients

排除标准

•Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
•Significant cardiovascular disease
•Significant diabetic complications
•Other protocol-defined inclusion/exclusion criteria may apply

结局指标

主要结局

Change from baseline on HbA1c at 12 weeks

次要结局

Change from baseline on fasting plasma glucose at 12 weeks
Change from baseline on HOMA B at 12 weeks
Change from baseline on HOMA IR at 12 weeks
Change from baseline in body weight at 12 weeks
Change from baseline on fasting lipids at 12 weeks

研究者

发起方

Novartis

申办方类型

Industry

研究点 (1)

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