临床试验/NCT00595374

NCT00595374已完成3 期

Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart to Insulin NPH Plus Insulin Aspart in Adults With Type 1 Diabetes Mellitus

Novo Nordisk A/S19 个研究点分布在 1 个国家目标入组 114 人开始时间: 2003年12月2日最近更新: 2017年2月24日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 114
试验地点: 19
主要终点: HbA1c

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 Europe.

The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
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

•Duration of type 1 diabetes for at least 12 months
•BMI below 35 kg/m2
•HbA1c between 7.0-12.0%
•Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months
•Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator

排除标准

•Known or suspected allergy to trial product or related products
•Previous participation in this trial
•Receipt of any investigational products within the last 2 months prior to this trial
•Drug or alcohol dependence
•Pregnancy, breast-feeding or intention of becoming pregnant

结局指标

主要结局

HbA1c

时间窗: after 26 weeks of treatment

次要结局

Plasma glucose profiles
Change in body weight
Quality of Life
Incidence of adverse events
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 (19)

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