临床试验/NCT01709929

NCT01709929已完成3 期

A Multicentre, Open Label, Nonrandomised, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

Novo Nordisk A/S0 个研究点目标入组 2,287 人开始时间: 2005年10月最近更新: 2016年3月3日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 2,287
主要终点: Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events

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记录与标识符相似试验

研究概览

简要总结

This trial is conducted in North America. The aim of this trial is to evaluate the safety of insulin detemir for the treatment of diabetes.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosed with type 1 or type 2 diabetes
•Using a basal/bolus insulin regimen

排除标准

•Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
•Subjects who previously enrolled in this study
•Subjects with a hypersensitivity to insulin detemir or to any of the excipients

研究组 & 干预措施

Insulin detemir

Experimental

干预措施: insulin detemir (Drug)

结局指标

主要结局

Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events

次要结局

Number of all hypoglycaemic events
Number of adverse events (all and serious)
HbA1c (glycosylated haemoglobin)
Change in weight
Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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