A Randomised, Single Centre, Double-Blind, Two-Period Crossover, Glucose Clamp Trial
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
Clinical pharmacology trials investigating insulin detemir in subjects with type 1 diabetes
have shown a prolonged and reproducible action profile of insulin detemir compared with NPH
insulin and insulin glargine. Duration of action of insulin detemir has been reported to be
up to 24 hours.9,10,11 It has, however, been proposed that the mean duration of action is
underestimated in glucose clamps lasting only 24 hours. This is so because a duration of
action longer than 24 hours in individual clamps will be set to 24 hours in the mean
calculation, whereas a shorter duration of action in individual clamps will be set to the
true value.
It has been shown in clinical pharmacology trials that NPL insulin has an action profile
comparable to NPH insulin in subjects with type 1 diabetes. , However, a direct comparison of
pharmacodynamic properties of insulin detemir and NPL insulin has not been performed to date.
To get further insight into the pharmacodynamic properties of insulin detemir compared with
NPL insulin, this trial has been designed to compare pharmacodynamics in general and duration
of action in particular between insulin detemir and NPL insulin in subjects with type 1
diabetes.