This trial is conducted in Europe. The aim of this trial is to compare different ratios of explorative formulations, not similar to the proposed commercial formulation, of IDegAsp (co-formulation of insulin degludec/insulin aspart and insulin aspart) with separately injected, simultaneous doses of insulin degludec (insulin 454), and insulin aspart, compared with biphasic insulin aspart 30 in male subjects with type 1 and type 2 diabetes mellitus. Trial part 1 is a five-period cross-over trial with incomplete block-design in subjects with type 1 diabetes where each subject will be randomised to five out of the ten possible treatments. Each treatment consists of an injection of the insulin product followed by a euglycemic clamp with a washout period of 7-15 days between treatments. Trial part 2 is a three-period cross-over trial with complete blockdesign in subjects with type 2 diabetes. Each treatment consists of an injection of the insulin product followed by a euglycaemic clamp with a washout period of 7-15 days between treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
59
Single dose administrated subcutaneously (s.c., under the skin).
Single dose administrated subcutaneously (s.c., under the skin).
Single dose administrated subcutaneously (s.c., under the skin).
Single dose administrated subcutaneously (s.c., under the skin).
Single dose administrated subcutaneously (s.c., under the skin).
Single dose administrated subcutaneously (s.c., under the skin) as comparator.
Single dose administrated subcutaneously (s.c., under the skin).
Single dose administrated subcutaneously (s.c., under the skin).
Single dose administrated subcutaneously (s.c., under the skin).
Unnamed facility
Neuss, Germany
Area under the insulin aspart concentration curve from 0-2 hours (for subjects with type 1 diabetes)
Time frame: 0-2 hours after dosing
Maximum glucose infusion rate divided by the average glucose infusion rate (for subjects with type 2 diabetes)
Time frame: 0-24 hours after dosing
Area under the glucose infusion rate curve
Time frame: 0-24 hours after dosing
Area under the serum insulin degludec concentration curve
Time frame: 0-96 hours after dosing
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