A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 1

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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Formulation 1<br> | Drug: insulin degludec/insulin aspart<br>* Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).<br>* Other names: IDegAsp;|
| Experimental: Formulation 2<br> | Drug: insulin degludec/insulin aspart<br>* Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).<br>* Other names: IDegAsp;|

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 (SD) | 
| Maximum observed serum insulin degludec concentration |  | After single-dose (within 0 to 120 hours after dosing) | 
| Area under the serum insulin aspart concentration-time curve |  | From 0 to 12 hours after single-dose | 
| Maximum observed serum insulin aspart concentration |  | After single-dose (within 0 to 12 hours after dosing) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |