Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 293
- 主要终点
- Change in HbA1c (Glycosylated Haemoglobin A1c)
研究概览
简要总结
This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.
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
- •Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months
- •HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both inclusive)
- •BMI (Body Mass Index) maximum 40 kg/m2
排除标准
- •Metformin contraindications according to local practice
- •Systemically treated with TZDs (thiazolidinediones) for more than one month within 6 months prior to this trial
研究组 & 干预措施
BIAsp 30-30
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
干预措施: biphasic insulin aspart 30 (Drug)
BIAsp 30-30
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
干预措施: metformin (Drug)
结局指标
主要结局
Change in HbA1c (Glycosylated Haemoglobin A1c)
时间窗: week 0, week 16
Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)
次要结局
- Change in 8-point Plasma Glucose Profile(week 0, week 16)
- Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%(week 16)
- Hypoglycaemic Episodes(weeks 0-16)
- Percentage of Subjects Achieving HbA1c Less Than 7.0%(week 16)
- Hypoglycaemic Episodes, Diurnal/Nocturnal(weeks 0-16)