Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
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.
Interventions
DRUGinsulin degludec
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).
DRUGinsulin degludec/insulin aspart 55
A single dose administered subcutaneously (s.c., under the skin).
DRUGinsulin aspart
A single dose administered subcutaneously (s.c., under the skin).
DRUGbiphasic insulin aspart 30
A single dose administered subcutaneously (s.c., under the skin).
DRUGplacebo
A single dose administered subcutaneously (s.c., under the skin).
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results * Diagnosed with type 1 diabetes and treated with insulin for above or equal to 12 months * Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
Exclusion criteria
* A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trialproduct, as judged by the Investigator * A subject who is known to have hepatitis or who is carrier of the Hepatitis B surface antibodies, or has a positive result to the test for HIV antigen (HBsAg) or Hepatitis C antibodies * A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the insulin aspart concentration curve | 0-2 hours after dosing |
Secondary
| Measure | Time frame |
|---|---|
| Area under the glucose infusion rate curve | 0-26 hours after dosing |
| Area under the serum insulin 454 concentration curve | 0-120 hours after dosing |
Countries
Germany
Outcome results
None listed