Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

Novartis Pharmaceuticals1 个研究点分布在 1 个国家目标入组 251 人开始时间: 2004年3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: 251
试验地点: 1
主要终点: Change from baseline in 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 was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.

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

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

排除标准

•Pregnancy or lactation
•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 12 weeks

次要结局

Adverse event profile after 12 weeks of treatment
Patients with reduction in HbA1c >/= 0.7% after 12 weeks
Change from baseline in fasting plasma glucose at 12 weeks
Change from baseline in HOMA-B at 12 weeks
Change from baseline in body weight at 12 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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