A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 1 Diabetes

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Japan. The aim of this clinical trial is to investigate the effect of NN1250 (insulin degludec) in Japanese subjects with type 1 diabetes.

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

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir; 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

• Current daily basal insulin requirement above or equal to 0.3 (I)U/kg/day

• Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0% (one retest within a week is permitted with the result of the last test being conclusive)

Exclusion Criteria:

• 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

• 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 and use of nicotine gum or transdermal nicotine patches during the inpatient period (only clamp period)