This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commerical formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Ascending single doses - 5 dose levels. Escalation to next dose level will be performed following evaluation of safety data.
Ascending single doses - 5 dose levels
A single dose corresponding to that of isophane human insulin
Unnamed facility
Neuss, Germany
Frequency of adverse events (trial part 1 only)
Time frame: From day prior to dosing and until 10-14 days after dosing
Area under the glucose infusion rate curve (trial part 2 only)
Time frame: 0-24 hours after dosing
Area under the serum insulin concentration curve
Time frame: 0-72 hours after dosing
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
A single dose of 0.4 IU/kg is administered to subjects with type 1 diabetes while a single dose of 0.6 IU/kg is administered to subjects with type 2 diabetes