临床试验/NCT00624364

NCT00624364已完成4 期

Comparison of Efficacy and Safety of Biphasic Insulin Aspart Plus Metformin to Biphasic Insulin Aspart Monotherapy in Subjects With Type 2 Diabetes

Novo Nordisk A/S16 个研究点分布在 1 个国家目标入组 140 人开始时间: 2004年5月最近更新: 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: 140
试验地点: 16
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 Africa. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone 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 99 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Type 2 diabetes
•Currently treated with maximum doses of any kind of OAD alone or any kind of oral combination therapy for at least 2 months
•Body mass index (BMI) below 40.0 kg/m2
•HbA1c between 7.5-13.0%

排除标准

•History of drug or alcohol dependence
•Mental incapacity, unwillingness or language barriers precluding adequate
•Subjects previously screened to participation or having already participated in this trial
•Receipt of any investigational drug within the last month prior to this trial
•Known or suspected allergy to trial products or related products

结局指标

主要结局

HbA1c

时间窗: after 24 weeks of treatment

次要结局

Plasma glucose profiles
Cardiovascular risk factors
Incidence of hypoglycaemic episodes
Adverse events

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (16)

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