Methods: In the present work, the pharmacodynamic glucose and insulin response was modeled by fitting glucose and insulin data simultaneously with a nonlinear model incorporating known carbohydrate regulation mechanisms. 9 h after NN2211 dosing the insulin response would then be expected to be improved (higher) in the subjects dosed with NN2211. In order to demonstrate effect in a phase 1 study including only healthy subjects, a glucose dose was administered i.v. Since NN2211 is only intended to have an effect when glucose levels are above baseline (thus limiting the risk of hypoglycaemia), no effects would be expected in healthy volunteers. In the present study, eight dose levels of NN2211 were tested in healthy human volunteers. Design: NN2211 is a GLP-1 derivative intended for the treatment of type 2 diabetes. Objective: To evaluate the effects of NN2211, a GLP-1 derivative, on glucose and insulin homeostasis in healthy volunteers by use of a nonlinear mixed-effects modeling approach.
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