Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in subjects with type 1 diabetes.

• 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:

• Subjects with type 1 diabetes treated with insulin for at least 12 months

• BMI (Body Mass Index) between 18.0-29.0 kg/m^2

• Negative fasting C-peptide (below or equal to 0.6 ng/mL)

• HbA1c (glycosylated haemoglobin A1c) below or equal to 10.0%

• Current treatment with insulin below or equal to 1.2 U/kg/day

• Subject should be in good health based on medical history, physical examination and routine laboratory data

Exclusion Criteria:

• Any known/suspected allergies to trial medication or similar products/devices

• A subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator

• Clinically significant active disease of any kind

• Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator

• Blood donation (more than 500 mL) within the previous 9 weeks