A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with type 2 diabetes.

Official Title
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A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 2 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin degludec/insulin aspart
* Drug: insulin degludec/insulin aspart
* Drug: insulin degludec/insulin aspart
* Drug: biphasic insulin aspart 30
* Drug: biphasic insulin aspart 30
* Drug: biphasic insulin aspart 30


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months Body mass index below or equal to 35.0 kg/m^2 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: 70 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: NN5401 - low dose<br> | Drug: insulin degludec/insulin aspart<br>* 0.4 U/kg body weight injected subcutaneously (under the skin) once<br>|
| Experimental: NN5401 - medium dose<br> | Drug: insulin degludec/insulin aspart<br>* 0.6 U/kg body weight injected subcutaneously (under the skin) once<br>|
| Experimental: NN5401 - high dose<br> | Drug: insulin degludec/insulin aspart<br>* 0.8 U/kg body weight injected subcutaneously (under the skin) once<br>|
| Active Comparator: biphasic insulin aspart 30 - low dose<br> | Drug: biphasic insulin aspart 30<br>* 0.4 U/kg body weight injected subcutaneously (under the skin) once<br>|
| Active Comparator: biphasic insulin aspart 30 - medium dose<br> | Drug: biphasic insulin aspart 30<br>* 0.6 U/kg body weight injected subcutaneously (under the skin) once<br>|
| Active Comparator: biphasic insulin aspart 30 - high dose<br> | Drug: biphasic insulin aspart 30<br>* 0.8 U/kg body weight injected subcutaneously (under the skin) once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate curve (only for IDegAsp) |  | From 0 to 24 hours after single-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the insulin aspart concentration-time curve |  | From 0 to 12 hours after single-dose administration | 
| Area under the insulin aspart concentration-time curve (only for BIAsp 30) |  | From 0 to 24 hours after single-dose administration |