临床试验/NCT01536600

NCT01536600已完成不适用

A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix 30 as Monotherapy, or in Combination With OHAs, in the Treatment of Type 2 Diabetic Patients in Routine Clinical Practice

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 33,010 人开始时间: 2004年9月最近更新: 2017年1月6日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 33,010
试验地点: 1
主要终点: Change in HbA1c (glycosylated haemoglobin)

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研究点记录与标识符相似试验

研究概览

简要总结

This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic agent (OHA) for type 2 diabetes management in routine clinical practice.

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: 否

入选标准

•Subjects with type 2 diabetes whose glycaemia was not optimally controlled with current therapy

排除标准

未提供

研究组 & 干预措施

BIAsp 30 users

干预措施: biphasic insulin aspart 30 (Drug)

结局指标

主要结局

Change in HbA1c (glycosylated haemoglobin)

次要结局

Adverse drug reactions (ADR)
Change in post prandial glucose (PPG)
Change in fasting glucose (FG)
Difference in prandial glucose increment (PGI)
Incidence of hypoglycaemic episodes

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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