临床试验/NCT00604253

NCT00604253已完成3 期

Comparison of Efficacy and the Safety of Insulin Detemir and Insulin NPH as add-on to Current OHA Therapy in Subjects With type2 Diabetes Mellitus

Novo Nordisk A/S2 个研究点分布在 1 个国家目标入组 362 人开始时间: 2003年12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: 362
试验地点: 2
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 Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in type 2 diabetes when added to current OHA treatment.

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

入选标准

•Duration of type 2 diabetes mellitus for at least one year
•Insulin naive patients
•OHA treatment for at least 12 weeks
•HbA1C between 7.5-10.0%
•Body Mass Index (BMI) below 30.0 kg/m2

排除标准

•Impaired renal function
•Impaired hepatic function
•Pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant or not using adequate contraceptive methods

结局指标

主要结局

HbA1c

时间窗: after 36 weeks of treatment

次要结局

Insulin antibodies
Incidence of hypoglycaemic episodes
Plasma glucose profiles
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 (2)

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