This trial was conducted in Europe. The aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes. The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)
Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)
Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
Novo Nordisk Investigational Site
Neuss, Germany
Area (AUC) under the glucose infusion rate curve
Time frame: From 0 to 24 hours after single-dose administration
Area (AUC) under the insulin aspart concentration time curve
Time frame: From 0 to 24 hours after single-dose administration
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Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)
Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)
Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)