A Trial to Investigate Different Needle Features Assessed by Comparing Insulin Aspart Pharmacokinetic Profiles

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 different needle features assessed by comparing insulin aspart Pharmacokinetics profiles (the exposure of the trial drug in the body)

Official Title
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A Single Centre, Randomised, 3-period Cross-over Trial to Investigate Different Needle Features Assessed by Comparing Insulin Aspart Pharmacokinetic Profiles

Conditions
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Diabetes

Intervention / Treatment
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* Drug: insulin aspart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial Male, age at least 18 years at time of signing informed consent Considered generally healthy upon completion of medical history, physical examination, analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator Body mass index (BMI) 28-39.9 kg/m^2 (overweight to obese) Caucasian Exclusion Criteria: Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) Non-fasting blood glucose test with blood glucose values above 11.1 millimol per liter (mmol/L) HbA1c (Glycosylated Haemoglobin) equal to or above 6.5% Known active or in-active skin disease in the injection area or that could affect pain perception History of deep leg vein thrombosis or repeated episodes of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the investigator Use of any prescription or non-prescription medication, including herbal products and nonroutine vitamins, within the last 2 weeks before screening Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the inpatient period Known or suspected abuse of alcohol (defined as regular intake of more than 14 units weekly for men where 1 unit equals 300 milliliter (mL) of beer, 100 mL of wine, or 25 mL of distilled spirits) Positive result of an alcohol breath test Known or suspected drug/chemical substance abuse within 1 year from screening

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 mm needle<br> | Drug: insulin aspart<br>* All subjects make three intervention visits with at least 5 days between individual intervention visits. At each intervention visit the subject receives one insulin aspart injection with only one type of needle.<br>|
| Experimental: 3.5 mm needle<br> | Drug: insulin aspart<br>* All subjects make three intervention visits with at least 5 days between individual intervention visits. At each intervention visit the subject receives one insulin aspart injection with only one type of needle.<br>|
| Active Comparator: 4 mm needle<br> | Drug: insulin aspart<br>* All subjects make three intervention visits with at least 5 days between individual intervention visits. At each intervention visit the subject receives one insulin aspart injection with only one type of needle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve insulin aspart measured in serum |  | During a maximum of 8 hours | 
| Maximum concentration of insulin aspart measured in serum |  | During a maximum of 8 hours |