Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

A Randomised, Single Centre, Two-period, Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin Detemir Formulations Containing Mannitol and Glycerol as Isotonic Agents Respectively, in Healthy Subjects

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.

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