Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes

A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Investigating the Pharmacokinetics and Pharmacodynamics of NN-X14Mix30 and NN-X14Mix50 in Type 2 Diabetic Patients

This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30 (NN-X14Mix30) and biphasic insulin aspart 50 (NN-X14Mix5050) in subjects with type 2 diabetes.

Inclusion Criteria:

• Type 2 diabetes
• Duration of diabetes for at least 1 year
• Body Mass Index (BMI) maximum 30.0 kg/m^2
• HbA1c maximum 10.0%

Exclusion Criteria:

• Recurrent severe hypoglycaemia
• Proliferative or preproliferative retinopathy diagnosed within the last 12 weeks or laser therapy for retinopathy within the last 12 weeks
• Impaired hepatic function
• Impaired renal function
• Cardiac problems
• Uncontrolled treated / untreated hypertension
• Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
• Total daily insulin dose exceeding 40 IU
• Treatment with OHAs (oral hypoglycaemic agents) or insulin preparations twice or more frequently a day
• Treatment with OHAs or insulin preparations once a day later than noon
• Subjects who smoke more than 15 cigarettes per day