This trial is conducted in Asia. The aim of this trial is to assess the safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of two insulin degludec/insulin aspart (IDegAsp) preparations and two insulin degludec (insulin 454) preparations in healthy Japanese male subjects. IDegAsp 45 (B) and insulin degludec (B) are explorative formulations, not similar to the proposed commercial formulations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
Unnamed facility
Tokyo, Japan
Adverse events (AEs)
Time frame: Day 1-6 and 7-28 days after day 6
Area under the serum insulin 454 concentration curve
Time frame: 0-96 hours after last dosing
Area under the serum insulin aspart concentration curve
Time frame: 0-6 hours after dosing
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