Pharmacokinetics of Insulin Aspart (IAsp) Following Continuous Subcutaneous Insulin Infusion (CSII) in Patients With Type 1 Diabetes Mellitus (T1DM)- Basal Rate Resolution.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- CV SSPIasp
研究概览
简要总结
The primary objective of the study is to compare SSPIAsp during CSII giving one bolus per hour compared with multiple boluses per hour.
The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion (CSII) versus continuous intravenous insulin infusion (CIII).
详细描述
Rapid acting insulin, like insulin aspart, can be administered as CSII. The insulin can be administered as a basal rate with additional insulin administration from the pump related to mealtimes.
Insulin is physiologically secreted in a pulsate manner from the pancreatic β-cells with a period of 5-10 minutes, and this is responsible for plasma insulin oscillations with similar frequency. The oscillatory pattern is believed to optimize control mechanisms of insulin to enhance its action on metabolism.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus (T1DM)
- •Insulin pump users' ≥ 48 hours, 24 h dose < 80 U
- •Insulin dose ≥ 0,4 IE/kg/24hours
- •18 years < age < 50 years
- •Time since diagnosis of T1DM ≥ 5 years
- •HbA1c ≤ 8,5 %
- •Safe anticonceptive for fertile women
- •Being able to understand and read Danish
排除标准
- •Dysregulation of endocrine disorders other than type 1 diabetes mellitus
- •Severe dysregulation of diabetes mellitus
- •Other severe adverse disease
- •Pregnancy, planning pregnancy, or nursing
研究组 & 干预措施
1
≈ bolus protocol.
干预措施: Insulin Aspart (IAsp) (Drug)
2
≈ CSII protocol
干预措施: Insulin Aspart (IAsp). (Drug)
3
≈ CIII protocol.
干预措施: Insulin Aspart (IAsp) (Drug)
结局指标
主要结局
CV SSPIasp
时间窗: 6 hours
次要结局
- • Δ SSPIAsp (S.C. /I.V.) • AUC IAsp • Tmax IAsp • Cmax IAsp - Bioequivalence of Iasp under SS (GIR, S-FFA, S-glycerol)(6 hours)