Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Insulin Aspart 30 Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 441
- 主要终点
- Change in Glycosylated Haemoglobin A1c (HbA1c)
研究概览
简要总结
This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.
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 premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months
- •HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive)
- •FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L
- •BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive)
排除标准
- •Metformin contraindications according to local practice
- •Systemic use of TZDs (thiazolidinediones) for more than 1 month within 6 months prior to this trial
研究组 & 干预措施
BIAsp 50-50-30
Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin
干预措施: biphasic insulin aspart 30 (Drug)
BIAsp 50-50-30
Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin
干预措施: metformin (Drug)
BIAsp 50-50-30
Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin
干预措施: biphasic insulin aspart 50 (Drug)
BIAsp 30-30
Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin
干预措施: biphasic insulin aspart 30 (Drug)
BIAsp 30-30
Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin
干预措施: metformin (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin A1c (HbA1c)
时间窗: week 0, week 16
Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)
次要结局
- The Total Increase in Total Daily Insulin Dose Per Body Weight(week 0, week 16)
- The Percentage of Subjects Achieving HbA1c Treatment Targets(week 16)
- Change and Daily Average in 8-point Plasma Glucose(week 0, week 16)
- Change in Body Weight(week 0, week 16)
- Number of Hypoglycaemic Episodes(weeks 0-16)
- Change and Daily Average in Prandial Plasma Glucose Increment(week 0, week 16)
- Number of Nocturnal Hypoglycaemic Episodes(weeks 0-16)