临床试验/NCT00568074

NCT00568074已完成4 期

Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chinese Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/S5 个研究点分布在 1 个国家目标入组 131 人开始时间: 2003年12月16日最近更新: 2017年2月20日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 131
试验地点: 5
主要终点: HbA1c

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 trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of repaglinide and Glurenorm® and Glucobay® given as the mono-therapy in Chinese subjects being treatment-naive type 2 diabetics.

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: None

入排标准

年龄范围: 30 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Type 2 diabetes
•No previous treatment for diabetes
•HbA1c: 7.0-12.0%

排除标准

•Type 1 diabetes
•Uncontrolled treated/untreated hypertension
•Any condition that the Investigator and/or Sponsor feels would interfere with trial participation or evaluation of results
•Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures (adequate contraceptive measures are: sterilisation, intra-uterine device (IUD), oral contraceptives or barrier methods)

结局指标

主要结局

HbA1c

时间窗: after 3 months of treatment

次要结局

hypoglycaemia episodes
adverse events
fasting blood glucose

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (5)

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