Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this trial is to test if there is bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin aspart 200 U/mL (U200) formulation.

Official Title
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A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial, Assessing the Bioequivalence Between Insulin Aspart 100 U/mL and Insulin Aspart 200 U/mL in Healthy Individuals

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: insulin aspart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Considered to be healthy as judged from vital signs, medical history, ECG (electrocardiogram), laboratory values, and physical examination Body mass index between 18 and 27 kg/m^2 (both inclusive) Non-smoker Fasting blood glucose maximum 6 mmol/L HbA1c below 6.4% Exclusion Criteria: Pregnant or breast-feeding women Women not using acceptable methods of contraception without difficulties for at least three months prior to trial start (screening), including intrauterine devices, oral contraceptives, hormonal implants, or sterilisation Clinically significant abnormal laboratory values (as judged by the Investigator) Close relative with type 1 diabetes mellitus (father, mother, sister or brother) Intake of alcohol within the last 24 hours prior to screening and drug administration visits Blood donation or blood loss of more than 500 mL within the 3 last months before screening Strenuous exercise within 48 hours before screening as well as drug administration and followup Smoking during the past month before drug administration

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: U200<br> | Drug: insulin aspart<br>* A single bolus injection of 0.2 U/kg administered subcutaneously (s.c., under the skin) on two separate dosing visits with a wash-out period 2-15 days in-between<br>|
| Active Comparator: U100<br> | Drug: insulin aspart<br>* A single bolus injection of 0.2 U/kg administered subcutaneously (s.c., under the skin) on two separate dosing visits with a wash-out period 2-15 days in-between<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) in the interval of 0-6 hours |  |  | 
| Cmax, maximum concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC in the interval of 0-infinity hours |  |  | 
| tmax, time to reach Cmax |  |  | 
| Terminal rate constant |  |  | 
| Vz/f, volume of distribution during terminal phase |  |  | 
| t½, terminal half-life |  |  | 
| AUCGIR, area under the glucose infusion rate value curve |  |  | 
| GIRmax, maximum glucose infusion rate value |  |  | 
| tGIRmax, time to maximum glucose infusion rate value |  |  | 
| Adverse events |  |  |