临床试验/NCT00600626

NCT00600626已完成3 期

Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus

Novo Nordisk A/S56 个研究点分布在 13 个国家目标入组 394 人开始时间: 2004年1月最近更新: 2017年1月6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: 394
试验地点: 56
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 and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 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 2 diabetes
•Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs
•HbA1c between 8.0-10.5%
•Body mass index (BMI) below 35.0 kg/m2
•Able and willing to perform self-monitoring of blood glucose

排除标准

•Total daily insulin dose of 1.80 IU/kg or more
•Known or suspected allergy to trial product or related products
•Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures

结局指标

主要结局

HbA1c

时间窗: after 4 months of treatment

次要结局

safety profiles
changes in body weight and vital signs
8-point blood glucose profile
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 (56)

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