This trial is conducted in Europe. The aim of this trial is to compare insulin degludec and insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30 (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high concentration were explorative formulations, not similar to the proposed commercial formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
55
Administered subcutaneously (s.c., under the skin).
A single dose administered subcutaneously (s.c., under the skin).
A single dose administered subcutaneously (s.c., under the skin).
A single dose administered subcutaneously (s.c., under the skin).
A single dose administered subcutaneously (s.c., under the skin).
A single dose administered subcutaneously (s.c., under the skin).
A single dose administered subcutaneously (s.c., under the skin).
A single dose administered subcutaneously (s.c., under the skin).
Unnamed facility
Neuss, Germany
Area under the insulin aspart concentration curve
Time frame: 0-2 hours after dosing
Area under the glucose infusion rate curve
Time frame: 0-26 hours after dosing
Area under the serum insulin 454 concentration curve
Time frame: 0-120 hours after dosing
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