A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic response (the effect of the investigated drug on the body) of insulin degludec/insulin aspart (IDegAsp) at steady state 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, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months

• Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months

• Body mass index (BMI) 18.0-28.0 kg/m^2 (both inclusive)

• Glycosylated haemoglobin (HbA1c) maximum 9.5 %

• Fasting C-peptide maximum 0.3 nmol/L

Exclusion Criteria:

• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)

• Not able or willing to refrain from smoking, use of nicotine gum or transdermal nicotine patches during the inpatient period

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

• Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening