A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Compare the Effects of 12 Weeks Treatment With Vildagliptin 50 mg Bid to Voglibose 0.2 mg Tid in Patients With Type 2 Diabetes

Novartis1 个研究点分布在 1 个国家目标入组 370 人开始时间: 2006年8月1日最近更新: 2007年6月28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: 370
试验地点: 1
主要终点: Change in HbA1c after 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 designed to evaluate the efficacy, safety and tolerability of vildagliptin compared to voglibose in patients with type 2 diabetes. Please note this study is not being conducted in the United States.

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 as 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 mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
•Significant heart diseases
•Significant diabetic complications
•Other protocol-defined inclusion/exclusion criteria may apply

结局指标

主要结局

Change in HbA1c after 12 weeks

次要结局

Change in FPG after 12 weeks
Change in Fasting Lipids after 12 weeks
Change in HOMA-IR after 12 weeks
Change in HOMA-B after 12 weeks
Safety Profile after 12 weeks treatment

研究者

发起方

Novartis

申办方类型

Industry

研究点 (1)

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