临床试验/NCT01486862

NCT01486862已完成4 期

NovoMix® 30 (Biphasic Insulin Aspart 70/30) Titrate-to-target: An Observational Study of the Efficacy of NovoMix® 30 in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs

Novo Nordisk A/S0 个研究点目标入组 26 人开始时间: 2005年10月最近更新: 2023年11月2日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 26
主要终点: Percentage of subjects achieving HbA1c (glycosylated haemoglobin A1c) below 7.0%

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This trial is conducted in North America. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on OADs (oral anti-diabetic drugs).

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
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 mellitus for at least 12 months
•HbA1c between 7.5-14.5% (inclusive) at screening
•Insulin naïve
•An antidiabetic regimen that has been stable for at least 3 months prior to screening
•An antidiabetic regimen that includes a minimum of 2 OADs

排除标准

•Use of any insulin preparations within the past 6 months
•Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening

研究组 & 干预措施

BIAsp 30

Experimental

干预措施: biphasic insulin aspart 30 (Drug)

结局指标

主要结局

Percentage of subjects achieving HbA1c (glycosylated haemoglobin A1c) below 7.0%

次要结局

Change in HbA1c
Total number of hypoglycemic events
Adverse events

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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