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临床试验/NCT01492166
NCT01492166已完成不适用

A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Mixtard® 30 NovoLet® as Monotherapy, or in Combination With Oral Hypoglycaemic Agent ( OHA ), in Treatment of Subjects With Type 2 Diabetes in Routine Clinical Practice

Novo Nordisk A/S1 个研究点 分布在 1 个国家目标入组 1,935 人开始时间: 2006年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1,935
试验地点
1
主要终点
Change in fasting blood glucose (FBG)

研究概览

简要总结

This study is conducted in Asia. The aim of this study is to assess the efficacy, safety and convenience of the use of Mixtard® 30 NovoLet® used alone or combined with oral hypoglycaemic agent (OHA) in the management of type 2 diabetes mellitus in an out-patient setting.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes
  • Not adequately controlled on their current therapy

排除标准

  • 未提供

研究组 & 干预措施

Novolet®

干预措施: biphasic human insulin 30 (Drug)

结局指标

主要结局

Change in fasting blood glucose (FBG)

Change in 2-hour post prandial blood glucose

Change in HbA1c (glycosylated haemoglobin)

Change in prandial glucose increment (PGI)

次要结局

  • Frequency of minor and major hypoglycaemia
  • Occurrence of Adverse Drug Reactions (ADR)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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