A Trial Investigating the Pharmacokinetic Properties of FIAsp in Children, Adolescents and Adults With Type 1 Diabetes

• Status: Completed
• Trial end date: 2014-07-24
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) properties of FIAsp (faster-acting insulin aspart) in children, adolescents and adults 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:

• Male or female aged 6-64 years (both inclusive) at the time of signing informed consent

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

• Body mass index (BMI) for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults equal to or below 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 screening

• Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)

• Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period