A Trial Investigating the Pharmacodynamic Properties of 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 this trial is to investigate the pharmacodynamic response (the effect of the investigated drug on the body) of insulin degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes.

Official Title
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A Trial Investigating the Pharmacodynamic Properties 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
* 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 at least 12 months Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months Body mass index (BMI) 18.0-28.0 kg/m^2 (both inclusive) Glycosylated haemoglobin (HbA1c) maximum 9.5 % Fasting C-peptide maximum 0.3 nmol/L Exclusion Criteria: 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, use of nicotine gum or transdermal nicotine patches during the inpatient period Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDeg-->IDegAsp<br> | Drug: insulin degludec<br>* Administered subcutaneously (s.c., under the skin) once daily (plus insulin aspart as bolus insulin as required).<br>Drug: insulin degludec/insulin aspart<br>* Single dose administered subcutaneously (s.c., 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 glucose infusion rate curve during one dosing interval |  | At steady state (0-24 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum glucose infusion rate (GIRmax) |  | At steady state (within 0-24 hours after last dosing) | 
| Area under the serum insulin degludec concentration-time curve during one dosing interval |  | At steady state (within 0-24 hours after last dosing) | 
| Maximum observed serum insulin degludec concentration |  | At steady state (within 0-24 hours after last dosing) | 
| Area under the serum insulin aspart concentration-time curve |  | From 0 to 12 hours | 
| Maximum observed serum insulin aspart concentration |  | Within 0-12 hours after dosing of IDegAsp |