临床试验/NCT00312104

NCT00312104已完成3 期

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes.

Novo Nordisk A/S47 个研究点分布在 3 个国家目标入组 325 人开始时间: 2002年4月最近更新: 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: 325
试验地点: 47
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 Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients 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: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Type 1 diabetes for at least 12 months
•Current daily insulin dose of more than 1.4 IU/kg
•BMI lesser than or equal to 35 kg/m2
•HbA1c greater than 7.5% and less than or equal to 12.0%
•In Austria, age more than 19 years

排除标准

•Proliferate retinopathy or maculopathy
•Recurrent major hypoglycaemia
•Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator

结局指标

主要结局

HbA1c

时间窗: after 26 weeks of treatment

次要结局

Blood glucose
Hypoglycaemia
Adverse events
Body weight

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (47)

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