Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes

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 compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.

Official Title
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A Double-blind, Randomised, Four-Period Crossover Trial Comparing the Pharmacodynamics and Pharmacokinetics After Single Dose of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Insulin Aspart in Subjects With Type 1 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 1

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: Type 1 diabetes for at least 12 months Serum C-peptide maximum 0.4 ng/mL Current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, NPH insulin, insulin detemir or insulin glargine BMI (Body Mass Index) maximum 32 kg/m^2 HbA1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory Non-smoker Exclusion Criteria: The receipt of any investigational drug within the last 30 days prior to this trial Total daily insulin dose at least 1.8 U/kg/day Current treatment with IAsp (insulin aspart) products A history of drug or alcohol abuse within the last 5 years Impaired hepatic function Impaired renal function Cardiac problems Severe, uncontrolled hypertension

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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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 |
| --- | --- |
| Active Comparator: BIAsp 30<br> | Drug: biphasic insulin aspart 30<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<br>Drug: biphasic insulin aspart 50<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<br>Drug: biphasic insulin aspart 70<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<br>Drug: insulin aspart<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<br>|
| Experimental: BIAsp 50<br> | Drug: biphasic insulin aspart 30<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<br>Drug: biphasic insulin aspart 50<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<br>Drug: biphasic insulin aspart 70<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<br>Drug: insulin aspart<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<br>|
| Experimental: BIAsp 70<br> | Drug: biphasic insulin aspart 30<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<br>Drug: biphasic insulin aspart 50<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<br>Drug: biphasic insulin aspart 70<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<br>Drug: insulin aspart<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<br>|
| Active Comparator: IAsp<br> | Drug: biphasic insulin aspart 30<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<br>Drug: biphasic insulin aspart 50<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<br>Drug: biphasic insulin aspart 70<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<br>Drug: insulin aspart<br>* A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between<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)-curves in the first two hours post-dosing |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum GIR value |  |  | 
| Time to maximum GIR value |  |  | 
| Area under the GIR-curves |  |  | 
| Maximum drug concentration for insulin aspart (IAsp) |  |  | 
| Time to maximum IAsp concentration |  |  | 
| Area under the curve of the IAsp profiles |  |  | 
| Minimum drug concentration in NEFA (Nonesterified fatty acids) |  |  | 
| Time to minimum plasma concentration, NEFA |  |  | 
| Area under the curve of the NEFA profiles |  |  | 
| Adverse events |  |  | 
| Hypoglycaemic episodes |  |  |