Type 1 Diabetes Mellitus Clinical Trial
Official title:
Pharmacokinetics of Insulin Aspart (IAsp) Following Continuous Subcutaneous Insulin Infusion (CSII) in Patients With Type 1 Diabetes Mellitus (T1DM)- Basal Rate Resolution.
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).
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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