Comparison of Single Dose and Steady State Pharmacodynamics 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 compare the single dose and steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.

Official Title
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A Double-blind, Randomised, Two-Period Crossover Trial Comparing the Single Dose and Steady State Pharmacodynamics 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 basal bolus treatment with soluble human insulin, Lispro and NPH insulin or Lantus. NPH insulin may be administered once or twice daily BMI (Body Mass Index) maximum 35 kg/m^2 Able and willing to perform self-blood glucose monitoring 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 Currently being treated with insulin aspart products A history of drug abuse or alcohol dependence within the last 5 years Impaired hepatic function Impaired renal function Blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory Cardiac problems 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. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods<br>Drug: biphasic insulin aspart 70<br>* Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods<br>|
| Experimental: Treatment period 2<br> | Drug: biphasic insulin aspart 30<br>* Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods<br>Drug: biphasic insulin aspart 70<br>* Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 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 |
| --- | --- | --- |
| Steady state area under the glucose infusion rate profile, 6-12 hours |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GIRmax, the maximal glucose infusion rate value |  |  | 
| tmax, time to maximum glucose infusion rate value |  |  | 
| area under the glucose infusion rate profile |  |  | 
| Time to 50% of area under the glucose infusion rate profile, 0-12 hours |  |  | 
| Cmax, maximum concentration |  |  | 
| tmax, time to reach Cmax |  |  | 
| Area under the curve |  |  | 
| t½, terminal half-life |  |  | 
| Adverse events |  |  |