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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

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