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

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

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.

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