A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of the trial is to compare 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) and insulin aspart (NovoRapid®) given as a bolus on top of a basal continuous subcutaneous insulin infusion (CSII).

Official Title
-----------------
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Faster-acting insulin aspart
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18-64 years (both inclusive) at the time of signing informed consent Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Body mass index (BMI) 18.5-28.0 kg/m^2 (both inclusive) Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months 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 at least one cigarette, cigar or pipe daily) Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FIAsp followed by NovoRapid®<br>Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days | Drug: Faster-acting insulin aspart<br>* Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion. The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump.<br>|
| Experimental: NovoRapid® followed by FIAsp<br>Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days | Drug: insulin aspart<br>* Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion. The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve |  | From 0 to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve |  | From 0 to 1 hour | 
| CSII bolus related baseline corrected area under the glucose infusion rate curve |  | From 0 to 1 hour |