Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese

A Single-centre, Randomised, Double Blind, Cross-over Trial Demonstrating the Bioequivalence Between NN2000-Mix30 and NN-X14Mix30 (NovoRapid® 30 Mix) in Healthy Japanese Subjects

This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese subjects.

Inclusion Criteria:

• Japanese
• Considered generally healthy based on medical history and physical examination
• Body Mass Index (BMI) between 18 and 27 kg/m^2 (both inclusive)
• Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL)

Exclusion Criteria:

• Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis
• Any serious systemic infectious disease that occurred during the last 4 weeks before trial
• Any inter-current illness that may affect blood glucose
• Subject with a first degree relative with diabetes mellitus
• Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 4 weeks