Investigation of the Response Relationship of NN5401 in Type 1 Diabetics

Study Overview
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Brief Summary
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This trial was conducted in Europe. The aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes. The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.

Official Title
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A Trial Investigating the Pharmacodynamic Response of 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
* 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 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Body mass index 18.0-28.0 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 screening Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic 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: 65 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: IDegAsp low<br> | Drug: insulin degludec/insulin aspart<br>* Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)<br>|
| Experimental: IDegAsp middle<br> | Drug: insulin degludec/insulin aspart<br>* Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)<br>|
| Experimental: IDegAsp high<br> | Drug: insulin degludec/insulin aspart<br>* Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)<br>|
| Experimental: BIAsp 30 low<br> | Drug: biphasic insulin aspart 30<br>* Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)<br>|
| Experimental: BIAsp 30 middle<br> | Drug: biphasic insulin aspart 30<br>* Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)<br>|
| Experimental: BIAsp 30 high<br> | Drug: biphasic insulin aspart 30<br>* Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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