A Trial Comparing the Effect of NN1250 After Different Routes of Injection in Healthy Subjects

Study Overview
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Brief Summary
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This trial was conducted in Europe. The aim of this clinical trial was to compare the exposure and effect of NN1250 (insulin degludec) after different routes of injection in healthy subjects.

Official Title
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A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties of NN1250 After Different Routes of Administration in Healthy Subjects

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: insulin degludec


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Considered generally healthy upon completion of medical history, physical examination, vital signs and ECG (electrocardiogram), as judged by the Investigator Body mass index 18.0-27.0 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 gum or transdermal nicotine patches during the inpatient period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDeg i.m. thigh<br> | Drug: insulin degludec<br>* Each subject was randomly allocated to five single dose administrations of NN1250 subcutaneously (under the skin) in the thigh, the abdomen (stomach) and the deltoid (shoulder), intramuscularly (into the muscle) in the thigh and intravenously (into the vein), respectively, on five separate dosing visits.<br>|
| Experimental: IDeg i.v.<br> | Drug: insulin degludec<br>* Each subject was randomly allocated to five single dose administrations of NN1250 subcutaneously (under the skin) in the thigh, the abdomen (stomach) and the deltoid (shoulder), intramuscularly (into the muscle) in the thigh and intravenously (into the vein), respectively, on five separate dosing visits.<br>|
| Experimental: IDeg s.c. abdomen<br> | Drug: insulin degludec<br>* Each subject was randomly allocated to five single dose administrations of NN1250 subcutaneously (under the skin) in the thigh, the abdomen (stomach) and the deltoid (shoulder), intramuscularly (into the muscle) in the thigh and intravenously (into the vein), respectively, on five separate dosing visits.<br>|
| Experimental: IDeg s.c. deltoid<br> | Drug: insulin degludec<br>* Each subject was randomly allocated to five single dose administrations of NN1250 subcutaneously (under the skin) in the thigh, the abdomen (stomach) and the deltoid (shoulder), intramuscularly (into the muscle) in the thigh and intravenously (into the vein), respectively, on five separate dosing visits.<br>|
| Experimental: IDeg s.c. thigh<br> | Drug: insulin degludec<br>* Each subject was randomly allocated to five single dose administrations of NN1250 subcutaneously (under the skin) in the thigh, the abdomen (stomach) and the deltoid (shoulder), intramuscularly (into the muscle) in the thigh and intravenously (into the vein), respectively, on five separate dosing visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum Insulin Degludec concentration-time curve (only for subcutaneous administration) |  | From 0 to 120 hours after single-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum Insulin Degludec concentration-time curve (only for intramuscular administration) |  | From 0 to 120 hours after single-dose | 
| Area under the serum Insulin Degludec concentration-time curve (only for intravenous administration) |  | From 0 to 30 hours after single-dose | 
| Maximum observed serum Insulin Degludec concentration after single-dose (only for subcutaneous and intramuscular administration) |  | Within 0 to 120 hours after dosing | 
| Back-extrapolated initial serum Insulin Degludec concentration after single-dose (only for intravenous administration) |  | At time zero after dosing |