Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects

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 demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.

Official Title
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A Randomised, Four-period Cross-over Trial in Healthy Subjects, Investigating the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Soluble Insulin Aspart

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: biphasic insulin aspart 30
* Drug: biphasic insulin aspart 50
* Drug: biphasic insulin aspart 70
* Drug: insulin aspart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index between 18 and 28 kg/m^2 inclusive HbA1c within the normal laboratory range Non smoker for at least three months Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods Exclusion Criteria: Subjects who have received any investigational drug in the 3 months prior to the start of dosing Any disease requiring regular use of non topical prescription medicines Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug Any intercurrent illness or endocrine disorders that may affect blood glucose Subject with a history of drug or alcohol dependence Subject with a first degree relative with diabetes mellitus Subject with a history of clinically relevant allergic reactions to medical products Subjects who have donated any blood or plasma in the past 3 month preceding screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: BIAsp 30<br> | Drug: biphasic insulin aspart 30<br>* One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days<br>|
| Experimental: BIAsp 50<br> | Drug: biphasic insulin aspart 50<br>* One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days<br>|
| Experimental: BIAsp 70<br> | Drug: biphasic insulin aspart 70<br>* One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days<br>|
| Active Comparator: Insulin aspart<br> | Drug: insulin aspart<br>* One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum GIR value |  |  | 
| Time to maximum GIR value |  |  | 
| Area under the GIR profile |  |  | 
| Cmax, maximum insulin aspart concentration |  |  | 
| Area under the insulin aspart concentration curve |  |  | 
| tmax, the time to maximum insulin aspart concentration |  |  | 
| t½, terminal half-life |  |  |