临床试验/NCT00698802

NCT00698802已完成2 期

Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes

Novo Nordisk A/S0 个研究点目标入组 397 人开始时间: 2008年6月最近更新: 2015年4月14日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 397
主要终点: HbA1c

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 Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.

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
•Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
•Body Mass Index (BMI) less than or equal to 40.0 kg/m2
•HbA1c less than or equal to 9.5%
•FPG (SMPG) less than or equal to 12 mmol/L

排除标准

•Treatment with more than 1IU/kg insulin daily
•Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
•Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
•Known or suspected allergy to trial products or related products
•Receipt of any investigational drug within one month prior to this trial
•Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers

研究组 & 干预措施

A

Experimental

干预措施: EX1000 (Drug)

B

Active Comparator

干预措施: biphasic human insulin (Drug)

结局指标

主要结局

HbA1c

时间窗: after 8 weeks of treatment

次要结局

HbA1c(For the duration of the trial)
Fructosamine(For the duration of the trial)
FPG(For the duration of the trial)
4-point SMPG profiles(For the duration of the trial)
Incidence of hypoglycaemic episodes(For the duration of the trial)
Frequency and severity of adverse events (including injection site reactions)(For the duration of the trial)
Laboratory safety parameters (haematology, biochemistry and lipids)(For the duration of the trial)
Physical examination and vital signs(For the duration of the trial)
Total daily insulin dosages(For the duration of the trial)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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