A Randomised Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes
Phase 1
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT02131246
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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) and pharmacodynamic (the effect of the investigated drug on the body) properties of faster-acting insulin aspart in subjects with Type 1 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Faster-acting insulin aspart Faster-acting insulin aspart Each subject will be allocated to two treatments (in random sequence). NovoRapid® insulin aspart Each subject will be allocated to two treatments (in random sequence).
- Primary Outcome Measures
Name Time Method Mean plasma glucose concentration From 0-6 hours after start of a standardised meal
- Secondary Outcome Measures
Name Time Method Area under the serum insulin aspart concentration-time curve From 0 to 12 hours after trial product administration
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇦🇹Graz, Austria