Comparison of Two Insulin Aspart Formulations in Healthy Volunteers

• Status: Completed
• Trial end date: 2002-10-18
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted in Africa. The aim of this trial is to determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).

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

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:

• Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant

• Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant

• Body mass index (BMI) 18-26 kg/m^2 (both inclusive)

• Weight 60-90 kg

• Non-smoker

Exclusion Criteria:

• Any condition requiring the regular use of any medication

• Known or suspected allergy to the trial product or related products

• Family history of type 1 diabetes mellitus