Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers

• Status: Completed
• Trial end date: 2002-12-20
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted in Europe. The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.

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

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

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

• Fasting blood glucose below or equal to 6 mmol/L

• Body Mass Index (BMI) 22.0-27.0 kg/m^2 (both inclusive)

Exclusion Criteria:

• Participated in another clinical study with an investigational drug within the last 4 weeks

• Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable

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

• Family history of type 1 diabetes