NCT00537277已完成4 期
A Titrate-To-Target Study of the Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs With / Without Once Daily Basal Insulin Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 161
- 主要终点
- Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%
研究概览
简要总结
This trial is conducted in Europe.
This is a clinical trial investigating the effectiveness and the safety of using biphasic insulin aspart 30 both for initiation and intensification of insulin treatment in type 2 diabetes.
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 more than 12 months
- •HbA1c: 7.5 - 11.0%
- •An antidiabetic regimen that has been stable for at least 3 months prior to screening
- •An antidiabetic regimen that includes a minimum of 2 oral anti-diabetic drugs (OADs) or 1 OAD plus evening or bedtime basal insulin
- •OADs dosed at 50% or more of the maximum recommended dose
排除标准
- •Use of any insulin preparations other than NPH or glargine within the past 6 months
- •Use of more than 60 units of insulin per day
- •Morning time insulin administration
- •Use of more than one insulin dose daily
研究组 & 干预措施
BIAsp 30
Experimental
Biphasic insulin aspart 30 administered once daily for 16 weeks. If HbA1c is higher than 7.0 % after 16 weeks of treatment, dose is increased to twice daily for another 16 weeks. If HbA1c is higher than 7.0 % after 32 weeks of treatment, dose is increased to three times daily until week 48 (end of trial).
干预措施: biphasic insulin aspart (Drug)
结局指标
主要结局
Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%
时间窗: week 48
次要结局
- Number of Hypoglycaemic Episodes(weeks 0-48)
- Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%(week 48)
- Number of Diurnal Hypoglycaemic Episodes(weeks 0-48)
- Number of Nocturnal Hypoglycaemic Episodes(weeks 0-48)
- Number of Treatment Emergent Serious Adverse Events (SAEs)(weeks 0-48)
研究者
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