An Extension Trial of BIAsp-3756, Explorative Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens on the Effect of Glycaemic Control in Chinese Type 2 Diabetes Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 179
- 主要终点
- Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline
研究概览
简要总结
This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic control of biphasic insulin aspart 30 twice daily with two different dosage split regimens for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Finalised 24 weeks of treatment with once daily BIAsp 30 or insulin glargine in combination with metformin and glimepiride in trial BIAsp-3756
- •HbA1c above or equal to 7.0%
- •Body Mass Index (BMI) below or equal to 40.0 kg/m2
排除标准
- •Known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in trial BIAsp-3756
- •Known proliferative retinopathy or maculopathy requiring acute treatment
- •Any disease or condition which the Investigator (trial physician) feels would interfere with the trial
研究组 & 干预措施
BIAsp 30 (2:1)
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
干预措施: biphasic insulin aspart 30 (Drug)
BIAsp 30 (2:1)
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
干预措施: metformin (Drug)
BIAsp 30 (1:1)
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
干预措施: biphasic insulin aspart 30 (Drug)
BIAsp 30 (1:1)
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
干预措施: metformin (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline
时间窗: Week 0, week 16
次要结局
- 9-point SMPG (Self Measured Plasma Glucose) Profile(Week 16)
- Percentage of Subjects Achieving HbA1c Below 7.0%(Week 16)
- Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%(Week 16)
- Number of Treatment Emergent Hypoglycaemic Episodes(Weeks 0-16)