临床试验/NCT00619697

NCT00619697已完成4 期

Comparison of Efficacy and Safety of Biphasic Insulin Aspart 30 Plus Metformin With Insulin Glargine Plus Glimepiride in Type 2 Diabetes

Novo Nordisk A/S55 个研究点分布在 6 个国家目标入组 260 人开始时间: 2003年12月1日最近更新: 2017年1月6日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 260
试验地点: 55
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. The aim of this trial is to investigate the efficacy on blood glucose control in 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 6 months
•Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed
•Previous treatment with oral antidiabetic drugs for at least 4 months
•Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen
•BMI below 40 kg/m2
•HbA1c between 7-12%
•Able and willing to perform self-plasma glucose monitoring

排除标准

•The receipt of any other investigational drug within 4 weeks before screening
•A history of drug or alcohol abuse within the last 12 months
•Severe, uncontrolled hypertension
•Known or suspected allergy to trial products or related products

结局指标

主要结局

HbA1c

时间窗: after 26 weeks of treatment

次要结局

HbA1c(after 16 weeks of treatment)
Plasma glucose profiles
Change in body mass index
Incidence of hypoglycaemic episodes
Safety profile

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (55)

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