Absorption of Insulin Following Subcutaneous Bolus Administration With Different Bolus Durations
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
To cover meal-related insulin requirements, insulin pumps allow insulin to be delivered at
high rates over a short period of time (bolus delivery). The length of this period (bolus
duration) usually depends on the chosen bolus size and on the used insulin pump model. This
study will evaluate the impact of different bolus durations (i.e., durations commonly
employed in commercially available insulin pumps: 2 and 40 seconds for delivering 1 Unit of
insulin) on the pharmacokinetic and pharmacodynamic properties of an rapid-acting insulin
analogue.
Objective: To evaluate in type 1 diabetic patients the pharmacodynamics and pharmacokinetics
of rapid-acting insulin (insulin lispro) administered as subcutaneous boluses with different
bolus durations.
Study design: Single-center, randomized, controlled, two-arm cross-over intervention study
Population: Twenty type 1 diabetic subjects
Intervention: The investigational treatment is the subcutaneous administration of insulin
lispro either as one bolus of 15 IU over a period of 30s or as one bolus of 15 IU over a
period of 10 min. 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 glucose infusion rate