临床试验/NCT01649570

NCT01649570已完成4 期

An Open-labelled, Single-arm, Multi-centre, 6-month Study to Investigate the Safety and Efficacy of NovoRapid as Meal Time Insulin in Type 2 Diabetes Patients Treated on a Basal-bolus Regimen With NPH Human Insulin

Novo Nordisk A/S0 个研究点目标入组 123 人开始时间: 2002年3月最近更新: 2012年7月25日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 123
主要终点: Incidence of hypoglycaemia

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者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 this trial is to investigate the safety and efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 20 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Type 2 diabetes
•Treated with insulin for at least 12 months and currently on a basal-bolus regimen for at least 12 weeks
•HbA1c below or equal to 11.0%
•BMI (body mass index) below 30 kg/m^2

排除标准

未提供

研究组 & 干预措施

Insulin aspart

Experimental

干预措施: insulin aspart (Drug)

结局指标

主要结局

Incidence of hypoglycaemia

次要结局

Incidence of adverse events (AEs)
Clinical laboratory tests: Haematology and biochemistry
Insulin antibodies
Glycaemic control parameters: Glycosylated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and post-prandial plasma glucose (PPPG)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

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