A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp 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 investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) in subjects with type 1 diabetes.

Official Title
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A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Faster-acting insulin aspart
* Drug: 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 Body mass index 18.5-28.0 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) Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period 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: FIASP<br>Each treatment period consists of 1 dosing visit during which the subject will receive a single dose of either insulin aspart or FIAsp at a predefined fixed dose level (in random sequence) in connection to intake of a standardised meal. | Drug: Faster-acting insulin aspart<br>* A single dose will be administered subcutaneously (under the skin) in the abdomen. Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days.<br>|
| Active Comparator: NovoRapid®<br>Each treatment period consists of 1 dosing visit during which the subject will receive a single dose of either insulin aspart or FIAsp at a predefined fixed dose level (in random sequence) in connection to intake of a standardised meal. | Drug: insulin aspart<br>* A single dose will be administered subcutaneously (under the skin)) in the abdomen. Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in plasma glucose concentration |  | From 0-2 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin aspart concentration-time curve |  | From 0 to 1 hour | 
| Area under the serum insulin aspart concentration-time curve |  | From 0 to 12 hours |