临床试验/NCT00097084

NCT00097084已完成3 期

Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

Novo Nordisk A/S61 个研究点分布在 5 个国家目标入组 324 人开始时间: 2004年9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: 324
试验地点: 61
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 purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy 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
•Treated with oral antidiabetic drugs or with any insulin regimen with or without oral antidiabetic drugs
•BMI of maximum 40 kg/m2
•HbA1c greater than or equal to 7.0% and less than or equal to 11.0%

排除标准

•Proliferative retinopathy or maculopathy
•Recurrent major hypoglycaemia
•Impaired hepatic or renal function
•Cardiac problems or uncontrolled hypertension

结局指标

主要结局

HbA1c

时间窗: after 1 year trial period

次要结局

Adverse events
Body weight
Hypoglycemia
Blood glucose
Insulin Treatment Satisfaction

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (61)

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