Comparison of the Efficacy and Safety of Step-wise Addition of Short Acting Insulin Analogue Insulin Aspart to Once Daily Insulin Detemir and Oral Anti-diabetic Treatment in Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Glycosylated Haemoglobin A1c (HbA1c)
研究概览
简要总结
This trial is conducted in Europe, Africa and the United States of America (USA).
The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment 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 —（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 6 months
- •HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)
- •BMI (Body Mass Index) less than 40 kg/m2
- •Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)
- •Treatment with one to 3 OADs
排除标准
- •Known or suspected allergy to trial products or related products
- •Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
- •Previous participation in any trial including this for the last 6 months
- •Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)
研究组 & 干预措施
Advanced
Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
干预措施: insulin detemir (Drug)
Advanced
Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
干预措施: insulin aspart (Drug)
Basic
Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
干预措施: insulin detemir (Drug)
Basic
Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
干预措施: insulin aspart (Drug)
结局指标
主要结局
Glycosylated Haemoglobin A1c (HbA1c)
时间窗: week 36
Measured for the Per Protocol analysis set.
次要结局
- Hypoglycaemic Episodes(Weeks 0-36)
- Biochemistry: Serum Alanine Aminotransferase(week 36)
- Haematology: Haemoglobin Measured in Blood(week 36)
- Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide(week 36)