临床试验/NCT00605137

NCT00605137已完成3 期

Safety of Insulin Detemir and Insulin NPH in Children With Type 1 Diabetes Mellitus

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 83 人开始时间: 2004年5月21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: 83
试验地点: 1
主要终点: Incidence of hypoglycaemic episodes

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 Japan. The aim of trial is to investigate the safety of insulin detemir and insulin NPH in children 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: 7 Years 至 18 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•Type 1 diabetes for at least one year
•Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart and/or soluble human insulin
•HbA1C below 11.0%
•Willing to comply with Investigator's instructions
•Able and willing to perform self-monitoring of capillary blood glucose and to take measures in case of hypoglycaemia

排除标准

•Impaired renal function
•Impaired hepatic function
•Known hypoglycaemia unawareness or recurrent major hypoglycaemia (as judged by the Investigator or Sub-Investigator)
•Proliferative retinopathy or maculopathy requiring acute treatment
•Uncontrolled treated/untreated hypertension
•Current treatment with total daily insulin dose of more than 2.00 IU/kg
•Current treatment or expected at the screening to start treatment with systemic corticosteroids

结局指标

主要结局

Incidence of hypoglycaemic episodes

时间窗: during treatment

次要结局

Laboratory assessments and other safety endpoints
HbA1C, self monitored blood glucose and within-subject variability of glucose
Height
Insulin doses
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 (1)

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