A Trial Investigating NN1218 in Subjects With Type 1 and Type 2 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 and type 2 diabetes.

Official Title
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A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 and Type 2 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 or type 2 diabetes mellitus for more than 12 months Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer for subjects with type 1 diabetes and for 3 months or longer for subjects with type 2 diabetes Body Mass Index (BMI) between 18.0-32.0 kg/m2 (both inclusive) Exclusion Criteria: Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to trial start 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: 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: NN1218, formulation A<br> | Drug: Faster-acting insulin aspart<br>* 0.2 U/kg body weight injected subcutaneously (under the skin)<br>* Other names: NN1218;|
| Experimental: NN1218, formulation B<br> | Drug: Faster-acting insulin aspart<br>* 0.2 U/kg body weight injected subcutaneously (under the skin)<br>* Other names: NN1218;|
| Experimental: NN1218, formulation C<br> | Drug: Faster-acting insulin aspart<br>* 0.2 U/kg body weight injected subcutaneously (under the skin)<br>* Other names: NN1218;|
| Experimental: NN1218, formulation D<br> | Drug: Faster-acting insulin aspart<br>* 0.2 U/kg body weight injected subcutaneously (under the skin)<br>* Other names: NN1218;|
| Active Comparator: insulin aspart<br> | Drug: insulin aspart<br>* 0.2 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 under the blood glucose concentration-time curve |  | from 0-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the blood glucose concentration-time curve |  | from 0-6 hours |