Comparison of the Impact of Biphasic Insulin Aspart 30 (BiAsp 30), Biphasic Insulin Aspart 70 (BiAsp 70) and Insulin Aspart on Postprandial Glucose and Lipid Metabolism During Two Consecutive Meals in Type 2 Diabetics.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area Over Basal for Postprandial Glucose From 0 to 600min
研究概览
简要总结
The aim of the study is to investigate meal-related treatment with either premixed Insulin Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free fatty acids excursions after a standard breakfast and lunch.
详细描述
Whereas the effects of each of the established types of insulin (remixed Insulin Aspart 30, Aspart 70 and Aspart) have been shown before, their specific glucose and lipid lowering capacities have so far not been investigated in a simulated physiological situation.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type-II Diabetes
- •BMI > 27 kg/m2
- •age 35 to 75 years
- •HbA1c < 8.5%
- •informed consent
- •treatment with pre-mixed insulin
- •stabile dose of insulin for at least 4 weeks
排除标准
- •Type-I Diabetes mellitus
- •HbA1c > 8.5 %
- •Serum Creatinine > 1.7 mg/dl
- •Alaninaminotranferase or Aspartataminotransferase > 3x Upper Limit of Normal
- •treatment with sulfonylurea or gliptins
- •treatment with glitazones
- •manifest clinical infections
- •treatment with glucocorticoids or antipsychotic drugs
- •psychiatric diseases
- •alcohol abuse
- •myocardial infarction or stroke within the previous 3 months
- •surgery within the previous 3 months
研究组 & 干预措施
Biphasic Insulin Aspart 30
35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch
干预措施: Insulin Aspart 30 (Drug)
Biphasic Insulin Aspart 70
35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch
干预措施: Insulin Aspart 70 (Drug)
Insulin Aspart
35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch
干预措施: Insulin Aspart (Drug)
结局指标
主要结局
Area Over Basal for Postprandial Glucose From 0 to 600min
时间窗: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Area over basal for postprandial glucose from 0 (Fasting glucose, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
Area Over Basal for Postprandial Triglycerides
时间窗: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Area over basal for postprandial triglycerides from 0 (Fasting triglycerides, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
次要结局
- Area Over Basal for Postprandial Insulin(0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start))
- Maximum Glucose Increase(0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start))
- Maximum Triglyceride Increase(0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start))
- Area Over Basal for Postprandial C-peptide(0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start))