Comparison of the Efficacy on Glycaemic Control and Safety Profile of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 Both in Combination With Metformin in Insulin-naïve Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Drugs (OADs) Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 145
- 主要终点
- Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals
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 and the safety profile of biphasic insulin aspart 30 compared to biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive subjects with type 2 diabetes when failing on oral antidiabetic drug (OAD) therapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes diagnosed for at least 6 months
- •Insulin-naive (less than or equal to 1 week of daily use of insulin therapy)
- •Treatment with metformin as monotherapy or in combination therapy with other OAD(s) for at least 3 months prior to this trial
- •Currently on metformin greater than or equal to 1000 mg/day for at least 2 weeks
- •Currently at least one of other OAD(s) reaching at least one-half of the recommended maximum dose for at least 2 weeks
- •Glycosylated haemoglobin (HbA1c) between 7.5-11.0%
- •Body Mass Index (BMI) between 18.5 - 35.0 kg/m^2
- •Be able and willing to perform continuous glucose monitoring system (CGMS ) and self-monitored blood glucose (SMBG)
排除标准
- •Known or suspected allergy to trial product(s) or related products
- •Any contraindication of metformin
- •Receipt of investigational drug within the last 3 months prior to this trial
- •Any history of chronic insulin therapy (more than 1 week of daily use)
- •Systemically treated with thiazolidinediones (TZDs) for more than one month within 6 months prior to this trial
- •Pregnancy, nursing mother, or unwillingness to use adequate contraception
研究组 & 干预措施
BIAsp 30
BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
干预措施: biphasic insulin aspart 30 (Drug)
BIAsp 30
BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
干预措施: metformin (Drug)
BHI 30
BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
干预措施: biphasic human insulin 30 (Drug)
BHI 30
BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
干预措施: metformin (Drug)
结局指标
主要结局
Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals
时间窗: Week 0, week 6
The blood glucose profiles were monitored by CGMS (Continuous Glucose Monitoring System) for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC was calculated using the trapezoidal method. The arithmetic mean of IAUC (3 meal-specific incremental areas) of day 1 and day 2 was used as the value of IAUC for each CGMS period
次要结局
- Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles(Week 0, Week 6)
- Change in Prandial Blood Glucose Increment(Week 0, Week 6)
- Mean FBG (Fasting Blood Glucose) Assessed by CGMS(Week 6)
- Duration of Hypoglycaemic Events Based on CGMS(72-hour monitoring period at Week 0 and Week 6)
- Change in Mean FBG Assessed by CGMS(Week 0, week 6)
- Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS(Week 0, Week 6)
- Change in FPG (Fasting Plasma Glucose)(Week 0, Week 6)
- Change in MAGE (Mean Amplitude of Glycaemic Excursions) Assessed by CGMS(Week 0, Week 6)
- Change in GA (Glycated Albumin)(Week -2, week 6)
- Change in Glycosylated Haemoglobin (HbA1c)(Week -2, week 6)
- Hypoglycaemia Based on Self-reported Episodes(Weeks 0-6)