A Randomised Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes
Status and phase
Completed
Phase 1
Conditions
Diabetes Mellitus, Type 1
Diabetes
Treatments
Drug: Faster-acting insulin aspart
Drug: insulin aspart
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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) and pharmacodynamic (the effect of the investigated drug on the body) properties of faster-acting insulin aspart in subjects with Type 1 diabetes.
Enrollment
33 patients
Sex
All
Ages
18 to 64 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Male or female 18-64 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 18.5-28.0 kg/m^2 (both inclusive)
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)
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
33 participants in 2 patient groups
Faster-acting insulin aspart
Experimental group
Description:
Each subject will be allocated to two treatments (in random sequence).
Treatment:
Drug: Faster-acting insulin aspart
NovoRapid®
Active Comparator group
Description:
Each subject will be allocated to two treatments (in random sequence).
Treatment:
Drug: insulin aspart
Trial contacts and locations
1
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems