临床试验/NCT00104182

NCT00104182已完成3 期

Efficacy and Safety Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening as Add-on to Oral Antidiabetic Drug(s) in Patients With Type 2 Diabetes

Novo Nordisk A/S97 个研究点分布在 4 个国家目标入组 503 人开始时间: 2005年2月最近更新: 2017年1月30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: 503
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 this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs 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 at least 12 months
•Currently treated with Oral Antidiabetic Drugs
•BMI lesser than or equal to 40 kg/m2
•HbA1c greater than or equal 7.5 and lesser than or equal to 11%

排除标准

•Proliferative retinopathy or maculopathy
•Recurrent major hypoglycaemia
•uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial

结局指标

主要结局

HbA1C

时间窗: after 20 weeks

次要结局

Hypoglycemia
Blood glucose
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 (97)

Loading locations...

相似试验

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

Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2

NCT00283751Novo Nordisk A/S583

已完成

3 期

The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2

NCT00856986Novo Nordisk A/S987

已完成

3 期

Efficacy and Safety of Insulin Detemir in Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1

NCT00595374Novo Nordisk A/S114