Comparison of the Accuracy and Precision of NovoLog® Mix 70/30 FlexPen® to Vial and Syringe in Patients With Type 2 Diabetes Mellitus

Novo Nordisk A/S2 个研究点分布在 1 个国家目标入组 60 人开始时间: 2005年7月最近更新: 2017年1月6日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 60
试验地点: 2
主要终点: Combined measure of accuracy and precision between target and measured amounts of insulin dispensed (mean square percent difference)

研究概览研究设计入排标准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 the United States of America (USA). The aim of this trial is to compare desired (target) with actual target amounts of insulin dispensed using NovoLog® Mix 70/30 FlexPen® and vial and syringe in subjects with type 2 diabetes mellitus. No insulin is administered in this trial - insulin is dispensed into an empty vial.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
盲法: None

入排标准

年龄范围: 40 Years 至 99 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Type 2 diabetes
•Insulin naive
•No previous experience administering injections

排除标准

•Any condition that, in the Investigator and/or Sponsor's opinion, could interfere with the results of this trial

结局指标

主要结局

Combined measure of accuracy and precision between target and measured amounts of insulin dispensed (mean square percent difference)

次要结局

Patient preference
Accuracy (mean relative error)
Precision (coefficient of variation)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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