An Open-labelled, Randomised, Parallel Group, 3 Week run-in and 24 Week Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Chinese and Japanese Insulin Naive Subjects With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 521
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Haemoglobin (HbA1c)
研究概览
简要总结
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine once daily both in combination with metformin and glimepiride in Chinese and Japanese subjects with type 2 diabetes who have never received insulin before.
The trial is conducted as a phase 4 trial in China and phase 3 in Japan.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes treated with a maximum of three different types of oral anti-diabetic drugs (OADs) (including traditional Chinese medicine which contains active ingredients of known OADs) for more than 6 months
- •Unchanged total daily dose of at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) metformin for the last two months
- •Unchanged total daily dose of at least half maximum recommended total daily dose of any insulin secretagogue for the last two months
- •Insulin naive
- •HbA1c between 7.0% and 10.0%
- •FPG (fasting plasma glucose) equal to or above 6.1 mmol/L (110mg/dL)
- •Body Mass Index (BMI) below 40.0 kg/m^2
排除标准
- •Treatment with any thiazolidinedione (TZD) and GLP-1 (glucagon like peptide-1) receptor antagonists during the last 3 months before Visit 1 in this trial
- •Any disease or condition which the Investigator feels would interfere with the trial
- •Any contraindication to metformin or glimepiride (according to local labelling)
研究组 & 干预措施
BIAsp 30
0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
干预措施: biphasic insulin aspart 30 (Drug)
BIAsp 30
0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
干预措施: metformin (Drug)
BIAsp 30
0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
干预措施: glimepiride (Drug)
Insulin glargine
0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
干预措施: metformin (Drug)
Insulin glargine
0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
干预措施: glimepiride (Drug)
Insulin glargine
0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
干预措施: insulin glargine (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c)
时间窗: Week 0, week 24
次要结局
- Percentage of Subjects Achieving HbA1c Below 7.0%(Week 24)
- 9-point Plasma Glucose Profiles(Week 24)
- Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%(Week 24)
- Number of Hypoglycaemic Episodes - All(Weeks 0-24)
- Number of Hypoglycaemic Episodes - Severe and Minor(Weeks 0-24)
- Number of Hypoglycaemic Episodes(Weeks 0-24)