A Multi-centre, Randomised, Open-labelled, 2-sequence, 2-period Crossover Trial to Investigate the Efficacy and Safety of Biphasic Insulin Aspart 50 (BIAsp 50) Twice Daily Versus Biphasic Human Insulin 50 (BHI 50) Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 161
- 主要终点
- 2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test
研究概览
简要总结
This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of biphasic insulin aspart 50 (BIAsp 50) twice daily versus biphasic human insulin 50 (BHI 50) twice daily, both in combination with metformin, in Chinese subjects with type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
- •Currently treated with premixed human insulin 50 BID for at least 3 months prior to screening visit (Visit 1)
- •Currently treated with unchanged total daily dose of at least 1500 mg metformin or maximum tolerated dose at least 1000 mg/day metformin for at least 2 months prior to screening visit
- •Glycosylated haemoglobin (HbA1c) 7.0% and 9.0% (both inclusive) (central laboratory)
排除标准
- •Treatment with any insulin secretagogue, alfa-glucosidase inhibitors, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to screening
- •Previous use of any insulin other than premixed human insulin 50 BID within 3 months prior to Visit 1
- •Previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more than 14 days
研究组 & 干预措施
Treatment sequence 1 (Group A)
Group A will receive BIAsp 50 BID during the first 4 weeks (treatment period 1) then switch to BHI 50 BID for further 4 weeks (treatment period 2)
干预措施: biphasic insulin aspart 50 (Drug)
Treatment sequence 1 (Group A)
Group A will receive BIAsp 50 BID during the first 4 weeks (treatment period 1) then switch to BHI 50 BID for further 4 weeks (treatment period 2)
干预措施: biphasic human insulin 50 (Drug)
Treatment sequence 2 (Group B)
Group B will receive BHI 50 BID during the first 4 weeks (treatment period 1), then switch to BIAsp 50 BID for further 4 weeks (treatment period 2)
干预措施: biphasic insulin aspart 50 (Drug)
Treatment sequence 2 (Group B)
Group B will receive BHI 50 BID during the first 4 weeks (treatment period 1), then switch to BIAsp 50 BID for further 4 weeks (treatment period 2)
干预措施: biphasic human insulin 50 (Drug)
结局指标
主要结局
2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test
时间窗: After 4 weeks of treatment in each treatment sequence
The 2-hour PPG increment is the difference between the plasma glucose (PG) value at 120 minutes after standard meal test and the fasting PG value.
次要结局
- The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile(After 4 weeks of treatment in each treatment sequence)
- Incidence of AEs (Adverse Event)(During 4 weeks of treatment in each treatment sequence)
- Incidence of Hypoglycemic Episodes(During 4 weeks of treatment in each treatment sequence)
- -1-hour PPG Increment Following a Standard Meal Test(After 4 weeks of treatment in each treatment sequence)
- -IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test(After 4 weeks of treatment in each treatment sequence)
- 2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile(After 4 weeks of treatment in each treatment sequence)