临床试验/NCT01542424

NCT01542424已完成不适用

A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 1,889 人开始时间: 2006年3月最近更新: 2017年1月31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: 1,889
试验地点: 1
主要终点: 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 trial is conducted in Europe. The aim of this trial is to investigate efficacy and safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects with type 1 or 2 diabetes mellitus.

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

•Macedonian people with diabetes mellitus (Type 1 or Type 2)

排除标准

未提供

研究组 & 干预措施

IDet users

干预措施: insulin detemir (Drug)

BIAsp 30 users

干预措施: biphasic insulin aspart 30 (Drug)

结局指标

主要结局

HbA1c (glycosylated haemoglobin)

次要结局

Fasting plasma glucose (FPG)
Percentage of subjects reaching HbA1c target of maximum 7.0%
Postprandial plasma glucose (PPG)
Change in body weight
Incidence of adverse events

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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