Bioequivalence of Two Insulatard® Formulations in Healthy Subjects

A Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulatard® (600 Nmol/ml) and Insulatard® (1998 Nmol/ml) in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to test for bioequivalence between two formulations of Insulatard® in healthy subjects.

Inclusion Criteria:

• Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
• Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2, inclusive
• Non-smoker, defined as no nicotine consumption for at least one year
• Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)

Exclusion Criteria:

• Previous participation in this trial or other clinical trials within the last 3 months
• Body weight above 87.5 kg
• 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, or sterilisation, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant)
• History of alcohol or drug abuse