Within-subject Variability of Insulin Detemir in Healthy Volunteers

• Status: Completed
• Trial end date: 2004-10-31
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.

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

Details

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

Criteria

Inclusion Criteria:

• Healthy Japanese men or women

• Holding a Japanese pass-port and Japanese-born parents

• Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator

• Body Mass Index (BMI) between 18 and 30 kg/m^2, incl.

• Fasting blood glucose maximum 6 mmol/L

Exclusion Criteria:

• Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator

• Any serious systemic infectious disease that occurred during the four weeks prior to the first dose of the trial product, as judged by the Investigator

• Subject with history of alcohol or drug dependence