临床试验/NCT00592969

NCT00592969已完成4 期

Evaluation of Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart or Insulin NPH in Subjects With Type 2 Diabetes

Novo Nordisk A/S3 个研究点分布在 2 个国家目标入组 164 人开始时间: 2003年12月3日最近更新: 2017年2月24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: 164
试验地点: 3
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 South America. The aim of this trial is to evaluate the efficacy of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects 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
•Currently treated with insulin NPH or are insulin-naive
•Body mass index (BMI) below 35.0 kg/m2
•HbA1c between 7.5-11.0%

排除标准

•Participation in any other clinical trial involving investigational products within the last 3 months
•History of drug or alcohol dependence
•Known impaired hepatic function
•Known or suspected allergy to human insulin NPH, insulin aspart or any component of the composition

结局指标

主要结局

HbA1c

时间窗: after 12 weeks of treatment

次要结局

Adverse events
Hypoglycemia
PPBG values
Glucose profiles

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (3)

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