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

• Status: Completed
• Trial end date: 2005-02-26
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

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