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临床试验/NCT01538589
NCT01538589已完成不适用

Special Survey for Type 1 or Type 2 Diabetic Patients

Novo Nordisk A/S0 个研究点目标入组 1,582 人开始时间: 2003年12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
1,582
主要终点
Adverse events

研究概览

简要总结

This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia under normal 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

入选标准

  • Patients with no treatment history of insulin aspart (NovoRapid®)

排除标准

  • 未提供

研究组 & 干预措施

Insulin aspart users

干预措施: insulin aspart (Drug)

结局指标

主要结局

Adverse events

时间窗: Year 2 for patients who had an antibody titre test performed

Occurrence of severe hypoglycaemic symptoms

时间窗: Year 2 for patients who had an antibody titre test performed

Antibody titre findings

时间窗: Year 2 for patients who had an antibody titre test performed

次要结局

  • Total dose of insulin infused subcutaneously(Year 2 for patients who had an antibody titre test performed)
  • Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control(Year 2 for patients who had an antibody titre test performed)
  • HbA1c (glycosylated haemoglobin)(Year 2 for patients who had an antibody titre test performed)

研究者

申办方类型
Industry
责任方
Sponsor

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