Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process
- Registration Number
- NCT01486914
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 28
Inclusion Criteria
- Healthy
- Caucasian
- Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
- Fasting blood glucose below or equal to 6 mmol/L
- Body mass index (BMI) 22.0-27.0 kg/m^2 (both inclusive)
Exclusion Criteria
- Participated in another clinical study with an investigational drug within the last 4 weeks
- Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
- Known or suspected allergy to the trial product or related products
- Family history of type 2 diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description NN2000 insulin aspart - IAsp insulin aspart -
- Primary Outcome Measures
Name Time Method Area under the Curve (AUC) (insulin aspart)
- Secondary Outcome Measures
Name Time Method Terminal half life (t½) Cmax (maximum plasma concentration) Adverse events Incident of hypoglycaemic episodes
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Manchester, United Kingdom