临床试验/NCT00646542

NCT00646542已完成3 期

A Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

Novartis0 个研究点目标入组 525 人开始时间: 2005年3月最近更新: 2020年12月17日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 525
主要终点: To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency.

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: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•History T2DM
•Moderate or Severe Renal Impairment

排除标准

•Glucose > 270 mg/dL (>15 mmol/L)
•Other protocol-defined inclusion/exclusion criteria may apply.

研究组 & 干预措施

1

Experimental

干预措施: Vildagliptin (Drug)

2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment

时间窗: 24 weeks

次要结局

To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency.(24 weeks)
To assess concentration levels of vildagliptin and its metabolites in patients with T2DM and moderate or severe renal insufficiency.(24 weeks)

研究者

发起方

Novartis

申办方类型

Industry

责任方

Sponsor

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