临床试验/NCT00312156

NCT00312156已完成3 期

Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes

Novo Nordisk A/S43 个研究点分布在 16 个国家目标入组 347 人开始时间: 2002年8月1日最近更新: 2017年1月27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: 347
试验地点: 43
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

The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of NPH Insulin once or twice daily combined with mealtime Insulin Aspart. The trial involves children and adolescents with Type 1 Diabetes.

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: 6 Years 至 17 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Type 1 diabetes for at least 12 months
•Informed consent obtained
•BMI: 6-7 years: less than or equal to 19 kg/m2, 8-9 years: less than or equal to 20 kg/m2, 10-11 years: less than or equal to 22 kg/m2, 12-13 years: less than or equal to 24 kg/m2 and 14-17 years: less than or equal to 27 kg/m
•HbA1c equal to or less than 12.0%

排除标准

•Proliferate retinopathy or maculopathy
•Total daily insulin dose greater than 2.00 IU/kg
•Any condition or disease that rule out trial participation according to the judgement of the investigator.
•Mental incapacity, unwillingness or language barriers precluding understanding or cooperation.
•A life-style incompatible with trial participation

结局指标

主要结局

HbA1c

时间窗: after 26 weeks

次要结局

Antibodies
Blood glucose
body weight
Hypoglycaemia
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 (43)

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