Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Japan. The aim of the trial is to compare pharmacokinetics (at which rate the body eliminates the substance from the body) of insulin aspart with fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection in Japanese subjects with type 1 diabetes mellitus.

• 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:

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

• Treated with multiple daily insulin injections for at least 12 months

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

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

• Body Mass Index (BMI) 18.0-28.0 kg/m^2

Exclusion Criteria:

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

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

• Subject who smokes more than 10 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