临床试验/NCT00283751

NCT00283751已完成3 期

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine as Add-on to Current Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes

Novo Nordisk A/S97 个研究点分布在 6 个国家目标入组 583 人开始时间: 2003年3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: 583
试验地点: 97
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 the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with 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 for more than 12 months, and no previous insulin treatment
•Oral Antidiabetic Drug treatment for at least 4 months
•Body Mass Index (BMI) less than 40 kg/m2
•HbA1c 7.5-10.0%

排除标准

•Current or previous treatment with thiazolidinediones within the last 6 months
•Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months
•Proliferative retinopathy or maculopathy
•Known hypoglycaemia unawareness

结局指标

主要结局

HbA1c

时间窗: after 52 weeks

次要结局

Insulin antibodies
Plasma glucose profiles
Incident of hypoglycaemic episodes and adverse events
Change in 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 (97)

Loading locations...

相似试验

已完成

3 期

Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2

NCT00104182Novo Nordisk A/S503

已完成

3 期

Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2

NCT00097084Novo Nordisk A/S324

已完成

3 期

Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1

NCT00095082Novo Nordisk A/S447

已完成

3 期

Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2

NCT00605020Novo Nordisk A/S719

已完成

3 期

Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1

NCT00435019Novo Nordisk A/S348