Pharmacokinetics of Biphasic Insulin Aspart 30 and 70 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 investigate steady state pharmacokinetics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.

Official Title
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A Single-Centre, Randomised, Double-Blind, 2- Period Crossover Trial Investigating the Steady State Pharmacokinetics of Biphasic Insulin Aspart 30 and Biphasic Insulin Aspart 70 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 70


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes for at least 12 months Currently on a multiple dose insulin regimen HbA1c maximum 12.0% BMI (body mass index) below 35 kg/m^2 Able and willing to perform self-blood glucose monitoring (SBGM) Exclusion Criteria: Treatment with insulin aspart within the last 14 days prior to this trial 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 A history of drug abuse or alcohol dependence within the last 5 years Impaired hepatic function Impaired renal function Blood donation within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory Cardiac disease Severe, uncontrolled hypertension

Ages Eligible for Study
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Minimum Age: 18 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: Treatment period 1<br> | Drug: biphasic insulin aspart 30<br>* Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.<br>Drug: biphasic insulin aspart 70<br>* Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.<br>|
| Experimental: Treatment period 2<br> | Drug: biphasic insulin aspart 30<br>* Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.<br>Drug: biphasic insulin aspart 70<br>* Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin curve 6-14 hours after dinner at day 15 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin curve 6-14 hours after dinner at day 1 |  |  | 
| Area under the serum insulin curve 0-6 hours after dinner |  |  | 
| Area under the curve 0-24 hours |  |  | 
| Serum insulin |  |  | 
| Apparent t½ (apparent elimination half life) |  |  | 
| Cmax, maximum concentration |  |  | 
| tmax, time to reach Cmax |  |  | 
| Adverse events |  |  |