A Comparison Between Two Formulations of NN5401 in Healthy Subjects

Study Overview
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Brief Summary
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This trial is conducted in the United States of America (USA). The aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in healthy subjects.

Official Title
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A Trial to Test for Bioequivalence Between Two NN5401 Formulations in Healthy Subjects

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: insulin degludec/insulin aspart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the physician Body mass index between 18.0 and 27.0 kg/m^2 (both inclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDegAsp B<br> | Drug: insulin degludec/insulin aspart<br>* Each subject will be allocated to two single injections of trial product on two separate dosing visits with each of the two insulin degludec/insulin aspart formulations. The trial products will be administered as a subcutaneous injection (under the skin).<br>|
| Experimental: IDegAsp F<br> | Drug: insulin degludec/insulin aspart<br>* Each subject will be allocated to two single injections of trial product on two separate dosing visits with each of the two insulin degludec/insulin aspart formulations. The trial products will be administered as a subcutaneous injection (under the skin).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin degludec concentration-time curve |  | from 0 to 120 hours after single-dose | 
| Maximum observed serum insulin degludec concentration |  | from 0 to 120 hours after single-dose | 
| Area under the serum insulin aspart concentration-time curve |  | from 0 to 12 hours after single-dose | 
| Maximum observed serum insulin aspart concentration |  | from 0 to 12 hours after single-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to maximum observed serum insulin degludec concentration |  | from 0 to 120 hours after single-dose | 
| Time to maximum observed serum insulin aspart concentration |  | from 0 to 12 hours after single-dose |