Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. The aim of this trial is to compare two formulations of insulin detemir containing an isotonic agent in healthy volunteers.

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

Details

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

Criteria

Inclusion Criteria:

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

• Body mass index (BMI) between 18 and 27 kg/m^2, inclusive

• Non-smoker

• Fasting plasma glucose maximum 6 mmol/L

Exclusion Criteria:

• Known or suspected allergy to trial products or related products

• Previous participation in this trial

• Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)

• The receipt of any investigational drug within the last 3 months prior to this trial