This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
Unnamed facility
Graz, Austria
Area under the serum insulin degludec concentration-time curve
Time frame: From 0 to 120 hours after single-dose (SD)
Maximum observed serum insulin degludec concentration
Time frame: After single-dose (within 0 to 120 hours after dosing)
Area under the serum insulin aspart concentration-time curve
Time frame: From 0 to 12 hours after single-dose
Maximum observed serum insulin aspart concentration
Time frame: After single-dose (within 0 to 12 hours after dosing)
Area under the glucose infusion rate curve
Time frame: From 0 to 26 hours after single-dose
Maximum glucose infusion rate
Time frame: After single-dose (within 0 to 120 hours after dosing)
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