Investigation of the Impact of Different Application Volumes of Insulin Aspart in Subjects With Type 1 Diabetes
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
Rationale: For the development of a closed loop system, faster insulin absorption after bolus
administration could help to reduce the system's delay and thus increase patient safety. It
has been shown that regular insulin absorption is faster when injecting insulin with a
sprinkler needle (containing holes in the walls and being sealed at the tip). The current
study will evaluate the impact of different application volumes on pharmacokinetic and
pharmacodynamic properties of rapid acting insulin analogue (insulin aspart).
Objective: To compare the pharmacokinetic response (based on the time to maximum observed
serum insulin concentration) and pharmacodynamic properties of rapid acting insulin aspart
after subcutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in
patients with type 1 diabetes.
Study design: Monocentric, randomised, controlled, two-arm cross-over intervention study.
Population: Twelve type 1 diabetic subjects
Intervention: The investigational treatment is the subcutaneous administration of insulin
aspart either as one bolus of 18 IU at one injection site or as 9 separately and
simultaneously applied bolus of 2 IU each at 9 separate injection sites. Serum and plasma
samples to assess pharmacodynamic and pharmacokinetic properties will be taken during an
8-hour clamp experiment. Patients will undergo both investigational treatments in a
randomized order; between the two clamp visits there will be a wash-out period of 5-21 days.
Main study endpoint: Time to maximum observed serum insulin aspart concentration.