A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 32
- Primary Endpoint
- Area under the serum insulin aspart concentration-time curve
Study Overview
Brief Summary
This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
- •Body mass index from 18.0 to 28.0 kg/m^2 (both inclusive)
- •HbA1c below or equal to 9.5% by central laboratory analysis
Exclusion Criteria
- •Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- •Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
- •Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Arms & Interventions
Formulation 1
Intervention: insulin degludec/insulin aspart (Drug)
Formulation 2
Intervention: insulin degludec/insulin aspart (Drug)
Outcomes
Primary Outcomes
Area under the serum insulin aspart concentration-time curve
Time Frame: From 0 to 12 hours after single-dose
Maximum observed serum insulin degludec concentration
Time Frame: After single-dose (within 0 to 120 hours after dosing)
Area under the serum insulin degludec concentration-time curve
Time Frame: From 0 to 120 hours after single-dose (SD)
Maximum observed serum insulin aspart concentration
Time Frame: After single-dose (within 0 to 12 hours after dosing)
Secondary Outcomes
- Area under the glucose infusion rate curve(From 0 to 26 hours after single-dose)
- Maximum glucose infusion rate(After single-dose (within 0 to 120 hours after dosing))