A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Area under the serum insulin aspart concentration-time curve
Study Overview
Brief Summary
This trial is conducted in Japan. The aim of the trial is to evaluate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
- •Body mass index (BMI) 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)
- •Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
Arms & Interventions
FIAsp
Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits
Intervention: Faster-acting insulin aspart (Drug)
FIAsp
Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits
Intervention: insulin aspart (Drug)
NovoRapid®
Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits
Intervention: Faster-acting insulin aspart (Drug)
NovoRapid®
Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits
Intervention: insulin aspart (Drug)
Outcomes
Primary Outcomes
Area under the serum insulin aspart concentration-time curve
Time Frame: From 0-1 hour
Secondary Outcomes
- Area under the serum insulin aspart concentration-time curve(From 0-12 hours)
- Area under the glucose infusion rate (GIR) curve(From 0-12 hours)