Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)

A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial, Assessing the Bioequivalence Between Insulin Aspart 100 U/mL and Insulin Aspart 200 U/mL in Healthy Individuals

This trial is conducted in Europe. The aim of this trial is to test if there is bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin aspart 200 U/mL (U200) formulation.

Inclusion Criteria:

• Considered to be healthy as judged from vital signs, medical history, ECG (electrocardiogram), laboratory values, and physical examination
• Body mass index between 18 and 27 kg/m^2 (both inclusive)
• Non-smoker
• Fasting blood glucose maximum 6 mmol/L
• HbA1c below 6.4%

Exclusion Criteria:

• Pregnant or breast-feeding women
• Women not using acceptable methods of contraception without difficulties for at least three months prior to trial start (screening), including intrauterine devices, oral contraceptives, hormonal implants, or sterilisation
• Clinically significant abnormal laboratory values (as judged by the Investigator)
• Close relative with type 1 diabetes mellitus (father, mother, sister or brother)
• Intake of alcohol within the last 24 hours prior to screening and drug administration visits
• Blood donation or blood loss of more than 500 mL within the 3 last months before screening
• Strenuous exercise within 48 hours before screening as well as drug administration and followup
• Smoking during the past month before drug administration